Clinical Trial - NCT02150967

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Recruiting

Sponsor: QED Therapeutics, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02150967

Protocol Info

Short Description: Phase II of BGJ398 in Adv. or Met. Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Alterations
Long Description: A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
MGH Status: Open
Sponsor: QED Therapeutics
Disease Program: GI

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.
Condition Title Intervention Phase
Advanced Cholangiocarcinoma FGFR2 Gene Mutation BGJ398 (infigratinib) Phase 2
Study Type Interventional
Official Title A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

Primary Outcome Measures

Overall response rate (ORR) [Time Frame: up to 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Overall survival [Time Frame: up to 24 months] [Designated as safety issue: ]

Progression free survival [Time Frame: up to 24 months] [Designated as safety issue: ]

Best overall response [Time Frame: up to 24 months] [Designated as safety issue: ]

Disease control rate [Time Frame: up to 24 months] [Designated as safety issue: ]

Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability [Time Frame: up to 24 months] [Designated as safety issue: ]

Selected trough and 2-hr or 4-hr Plasma concentration profile [Time Frame: up to 12 months] [Designated as safety issue: ]

Estimated Enrollment: 160
Study Start Date: July 2014
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: March 2022
Arms Assigned Interventions

Experimental:BGJ398 (infigratinib)

To estimate anti-tumor activity of BGJ398
Drug:BGJ398 (infigratinib)
Capsule for oral use

Eligibility

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

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion criteria:

  • Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.

Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

  • Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.

Exclusion criteria:

  • Prior or current treatment with a MEK inhibitor (all cohorts), BGJ398/infigratinib (all cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).
  • insufficient organ function
  • Absolutely Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 109/L]
  • Platelets < 75,000/mm3 [75 x 109/L]
  • Hemoglobin < 109.0 g/dL
  • Total bilirubin > 1.5x ULN
  • Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN (AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver metastases)
  • Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance < 45 mL/min
  • Inorganic phosphorus outside of normal limits
  • Total and ionized serum calcium outside of normal limits

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02150967

Locations

  • United States, Arizona
    • QED Investigative Site Phoenix, Arizona, United States, 85054
  • United States, California
    • QED Investigative Site Los Angeles, California, United States, 90033
    • QED Investigative Site Los Angeles, California, United States, 90095
    • QED Investigative Site San Francisco, California, United States, 94143
  • United States, Massachusetts
    • QED Investigative Site Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • QED Investigative Site Detroit, Michigan, United States, 48201
  • United States, New York
    • QED Investigative Site New York, New York, United States, 10029
    • Memorial Sloan Kettering Cancer Center Sloan Onc Dept. New York, New York, United States, 90033
  • United States, Ohio
    • QED Investigative Site Columbus, Ohio, United States, 43221
  • United States, Texas
    • University of Texas/MD Anderson Cancer Center Onc. Dept, Houston, Texas, United States, 77030-4009
  • Belgium,
    • QED Investigative Site Bruxelles, , Belgium, 1200
    • QED Investigative Site Leuven, , Belgium, 3000
  • Germany, Nordrhein-Westfalen
    • QED Investigative Site Koeln, Nordrhein-Westfalen, Germany, 50937
  • Germany,
    • QED Investigative Site Heidelberg, , Germany, 69120
  • Italy, AN
    • QED Investigative Site Ancona, AN, Italy, 60126
  • Italy, MI
    • QED Investigative Site Milano, MI, Italy, 20132
  • Italy, RM
    • QED Investigative Site Roma, RM, Italy, 00168
  • Korea, Republic of, Korea
    • QED Investigative Site Seoul, Korea, Korea, Republic of, 03080
    • QED Investigative Site Seoul, Korea, Korea, Republic of, 06351
  • Russian Federation,
    • QED Investigative Site Moscow, , Russian Federation, 125367
    • QED Investigative Site Volzhsky, , Russian Federation, 404133
  • Singapore,
    • QED Investigative Site Singapore, , Singapore, 119228
    • QED Investigative Site Singapore, , Singapore, 169610
  • Spain, Catalunya
    • QED Investigative Site Barcelona, Catalunya, Spain, 08035
  • Spain,
    • QED Investigative Site Madrid, , Spain, 28050
  • Taiwan, Taiwan ROC
    • QED Investigative Site Taipei, Taiwan ROC, Taiwan, 10041
  • Taiwan,
    • QED Investigative Site Taipei, , Taiwan, 10002
  • Thailand, THA
    • QED Investigative Site Khon Kaen, THA, Thailand, 40002
  • Thailand,
    • QED Investigative Site Bangkok, , Thailand, 10330
    • QED Investigative Site Bangkok, , Thailand, 10400

Sponsors and Collaborators

QED Therapeutics, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02150967
Other Study ID Numbers: 2013-005085-19
Study First Received:
Last Updated:
Health Authority:

Keywords provided by QED Therapeutics, Inc.:

cholangiocarcinoma,

FGFR2 gene fusion,

FGFR genetic alteration

Additional relevant MeSH terms:

Cholangiocarcinoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019