Clinical Trial - NCT01970865

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Active, not recruiting

Sponsor: Pfizer

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT01970865

Protocol Info

Short Description: Phase 1/2 PF-06463922 in Advanced NSCLC
Long Description: Phase 1/2 Study of PF-06463922 (an ALK/ROS1 Tyrosine Kinase Inhibitor) In Patients With Advanced Non-Small Cell Lung Cancer Harboring Specific Molecular Alterations
MGH Status: Closed
Sponsor: Pfizer
Disease Program: Thoracic

Next Steps


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Purpose

Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .
Condition Title Intervention Phase
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC PF-06463922 Crizotinib Phase 2
Study Type Interventional
Official Title PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS

Primary Outcome Measures

Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 [Time Frame: Cycle 1 (21 days)] [Designated as safety issue: ]

Percentage of Participants With Overall and Intracranial Objective Response (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]


Secondary Outcome Measures

Percentage of Participants With Overall and Intracranial Objective Response (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Time to Tumor Response (TTR) and Intracranial TTR (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Duration of Response (DOR) and Intracranial DOR (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 1) [Time Frame: 12 weeks] [Designated as safety issue: ]

Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Progression-Free Survival (PFS) (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Overall Survival (OS) (Phase 1) [Time Frame: 3 years] [Designated as safety issue: ]

Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).] [Designated as safety issue: ]

Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Time for Cmax (Tmax) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, and 24 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Apparent Oral Clearance (CL/F) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)] [Designated as safety issue: ]

Apparent Volume of Distribution (Vz/F) of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)] [Designated as safety issue: ]

Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.] [Designated as safety issue: ]

Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)] [Designated as safety issue: ]

Renal Clearance (CLr) of PF-06463922 (Phase 1) [Time Frame: 0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Percent of PF-06463922 Recovered Unchanged in Urine up to Dosing Interval (AEtau%) (Phase 1) [Time Frame: 0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Time for Cmax (Tmax) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Apparent Oral Clearance (CL/F) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Terminal Half-Life of Midazolam (Phase 1) [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 1) [Time Frame: Screening] [Designated as safety issue: ]

Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1) [Time Frame: Screening] [Designated as safety issue: ]

Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1) [Time Frame: Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)] [Designated as safety issue: ]

Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1) [Time Frame: Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1) [Time Frame: Baseline, Day 1 of each cycle, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Time to Tumor Response (TTR) and Intracranial TTR (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Duration of Response (DOR) and Intracranial DOR (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 2) [Time Frame: 12 weeks] [Designated as safety issue: ]

Time to Progression (TTP) on the Last Prior Therapy (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Time to Tumor Progression (TTP) and Intracranial TTP (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Progression-Free Survival (PFS) (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Overall Survival (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Time for Cmax (Tmax) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7] [Designated as safety issue: ]

Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Apparent Volume of Distribution (Vz/F) of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7] [Designated as safety issue: ]

Terminal Half-Life of PF-06463922 (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7] [Designated as safety issue: ]

Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 2) [Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15] [Designated as safety issue: ]

Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 2) [Time Frame: Screening] [Designated as safety issue: ]

Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 2) [Time Frame: Screening] [Designated as safety issue: ]

Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants With Treatment-Emergent Adverse Events (Phase 1 and Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Hematology [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Chemistry [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Coagulation, Lipids and Urinalysis [Time Frame: 3 years] [Designated as safety issue: ]

Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1 and Phase 2) [Time Frame: Baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25 for Phase 1 (Cycles 2-38 for Phase 2), Day 1 of every other cycle thereafter, end of treatment (up to 3 years)] [Designated as safety issue: ]

Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Percent in Left Ventricular Ejection Fraction (LVEF) (Phase 1 and Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-3, Day 1 of every other cycle from Cycle 5 up to 18 months for Phase 1 (up to 30 months for Phase 2), every 4 cycles thereafter, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1 and Phase 2) [Time Frame: Phase 1: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25, end of treatment (up to 3 years); Phase 2: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-5, end of treatment (up to 3 years)] [Designated as safety issue: ]

Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2) [Time Frame: 3 years] [Designated as safety issue: ]

Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2) [Time Frame: Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)] [Designated as safety issue: ]

Estimated Enrollment: 334
Study Start Date: January 2014
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: March 2017
Arms Assigned Interventions

Experimental:PF-06463922

Drug:PF-06463922
Oral, starting dose 10mg once a day, dose escalation in Phase 1 until recommended Phase 2 dose determined, continuous daily dosing, cycles lasting 21 days

Other:Crizotinib

ALK+ NSCLC patients who are treatment naïve may be eligible to receive crizotinib following PF-06463922 as a substudy to the main study.
Drug:Crizotinib
Oral, starting dose of 250 mg BID continuous daily dosing every 21 days

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria

  • Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
  • Disease Status Requirements:

Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK/ROS1 inhibitor therapy(ies).

Phase 2:

ALK-positive NSCLC patients must either be or have had:

  • Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed).
  • Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting.
  • Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the metastatic disease setting.
  • Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting.
  • Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
  • Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.

ROS1-positive NSCLC patients may be:

  • Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy).
  • Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).
  • Tumor Requirements:

All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible.

  • Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.
  • Negative Serum pregnancy test for females of childbearing potential Exclusion Criteria
  • Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry.
  • Systemic anti cancer therapy completed within a minimum of 5 half lives of study entry.
  • Prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody.
  • Active and clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
  • Clinically significant cardiovascular disease (that is, active or <3 months prior to enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome.
  • History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis.
  • Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970865

Locations

  • United States, Arkansas
    • Highlands Oncology Group/Research Fayetteville, Arkansas, United States, 72703
    • Highlands Oncology Group Rogers, Arkansas, United States, 72758
  • United States, California
    • Chao Family Comprehensive Cancer Center Orange, California, United States, 92868-3201
    • UC Irvine Medical Center Orange, California, United States, 92868-3201
  • United States, Colorado
    • University of Colorado Cancer Center Aurora, Colorado, United States, 80045
    • University of Colorado Hospital Aurora, Colorado, United States, 80045
  • United States, Connecticut
    • MDZ: Yale-New Haven Hospital New Haven, Connecticut, United States, 06504
    • Smilow Cancer Hospital at Yale-New Haven New Haven, Connecticut, United States, 06510
  • United States, District of Columbia
    • Georgetown University Medical Center Washington, District of Columbia, United States, 20007
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Brigham and Women's Hospital Boston, Massachusetts, United States, 02115
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Karmanos Center Institute Detroit, Michigan, United States, 48201
    • Karmanos Cancer Institute Farmington Hills, Michigan, United States, 48334
  • United States, Missouri
    • Siteman Cancer Center-West County Creve Coeur, Missouri, United States, 63141
    • Barnes-Jewish Hospital Saint Louis, Missouri, United States, 63110
    • Washington University Infusion Center Pharmacy Saint Louis, Missouri, United States, 63110
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Siteman Cancer Center-South County Saint Louis, Missouri, United States, 63129
  • United States, New York
    • Rockefeller Patient Pavilion - Memorial Sloan Kettering New York, New York, United States, 10022
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
    • Rochester Regional Health System Rochester, New York, United States, 14621
    • SUNY Upstate Medical University Syracuse, New York, United States, 13210
  • United States, Ohio
    • The Ohio State University Columbus, Ohio, United States, 43205
    • The Ohio State University Columbus, Ohio, United States, 43210
    • The Ohio State University Columbus, Ohio, United States, 43221
  • United States, Pennsylvania
    • Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111
  • United States, Tennessee
    • Sarah Cannon Research Institute (Pharmacy) Nashville, Tennessee, United States, 37203
  • Australia, New South Wales
    • Chris O'Brien Lifehouse Sydney Local Health District [rpa], New South Wales, Australia, 2050
    • Chris O'Brien Lifehouse Sydney, New South Wales, Australia, 2050
    • Royal Prince Alfred Hospital Sydney, New South Wales, Australia, 2050
  • Australia, Victoria
    • Peter MacCallum Cancer Centre Melbourne, Victoria, Australia, 3000
    • Royal Melbourne Hospital Parkville, Victoria, Australia, 3050
  • Belgium,
    • University Hospital Antwerp Edegem, , Belgium, 2650
  • Canada, British Columbia
    • British Columbia Cancer Agency-Vancouver Centre Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Ontario
    • The Ottawa Hospital Cancer Centre Ottawa, Ontario, Canada, K1H 8L6
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • France,
    • CHU Grenoble/ Hôpital Albert Michallon Grenoble Cedex 9, , France, 38043
    • CHU Grenoble/Hopital Albert Michallon Grenoble Cedex 9, , France, 38043
    • CHU de Rennes - Hôpital Pontchaillou - CIC Inserm Rennes Cedex 9, , France, 35033
    • CHU de Rennes - Hôpital Pontchaillou Rennes Cedex 9, , France, 35033
    • Institut Universitaire du Cancer de Toulouse (IUCT-O) Toulouse Cedex 9, , France, 31059
    • Institut Gustave Roussy (comite poumon-pneumologie) Villejuif Cedex, , France, 94805
  • Germany, NRW
    • Universitaetsklinik Koeln Cologne, NRW, Germany, 50937
  • Hong Kong,
    • Department of Clinical Oncology, Prince of Wales Hospital Shatin, , Hong Kong,
  • Italy,
    • Struttura Operativa Complessa Oncologia Aviano (PN), , Italy, 33081
    • Dipartimento di Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative Milano, , Italy, 20132
    • Unita di Farmacologia Clinica e Nuovi Farmaci Milano, , Italy, 20141
    • Oncologia Medica Perugia, , Italy, 06132
  • Japan, Aichi
    • Aichi cancer center central hospital Nagoya, Aichi, Japan, 464-8681
    • Nagoya University Hospital Nagoya, Aichi, Japan, 466-8560
  • Japan, Chiba
    • National Cancer Center Hospital East Kashiwa, Chiba, Japan, 277-8577
  • Japan, Ehime
    • National Hospital Organization Shikoku Cancer Center Matsuyama, Ehime, Japan, 791-0280
  • Japan, Hokkaido
    • Hokkaido University Hospital Sapporo, Hokkaido, Japan, 060-8648
  • Japan, Hyogo
    • Hyogo Cancer Center Akashi, Hyogo, Japan, 673-8558
  • Japan, Osaka
    • Kinki University Hospital Osakasayama, Osaka, Japan, 589-8511
  • Japan, Shizuoka
    • Shizuoka Cancer Center Sunto-gun, Shizuoka, Japan, 411-8777
  • Japan, Tokyo
    • National Cancer Center Hospital Chuo-ku, Tokyo, Japan, 104-0045
  • Japan,
    • National Hospital Organization Kyushu Cancer Center Fukuoka, , Japan, 811-1395
    • The Cancer Institute Hospital of JFCR Koto-ku, Tokyo, , Japan, 135-8550
  • Korea, Republic of,
    • Seoul National University Hospital / Department of Internal Medicine Seoul, , Korea, Republic of, 03080
    • Seoul National University Hospital Seoul, , Korea, Republic of, 03080
  • Singapore,
    • National University Hospital Singapore, , Singapore, 119074
    • National University Hospital Medical Centre Singapore, , Singapore, 119082
    • National Cancer Center Singapore, , Singapore, 169610
  • Spain, Madrid
    • Hospital Universitario Quiron Madrid Pozuelo de Alarcón, Madrid, Spain, 28223
  • Spain, Navarra
    • Clinica Universidad de Navarra Pamplona, Navarra, Spain, 31008
  • Spain,
    • Hospital Universitario Quiron Dexeus Barcelona, , Spain, 08028
    • Hospital Universitari de la Vall D'Hebron Edificio General. Planta Baja. UITM. Servicio de Oncologia Barcelona, , Spain, 08035
  • Switzerland,
    • Hospital of Lausanne (CHUV) Lausanne, , Switzerland, 1011
    • Kantonsspital Winterthur Winterthur, , Switzerland, 8401
  • Taiwan,
    • National Taiwan University Hospital Taipei, , Taiwan, 100

Sponsors and Collaborators

Pfizer

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT01970865
Other Study ID Numbers: 2013-002620-17
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Pfizer:

Phase 1

Phase 2

safety

pharmacokinetic

pharmacodynamic

efficacy

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Crizotinib

Next Steps


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ClinicalTrials.gov processed this data on August 15, 2019