Clinical Trial - NCT03002805

CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin

Recruiting

Sponsor: CBA Research

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03002805

Protocol Info

Short Description: Phase I of CBT-1 + Doxorubicin in Locally Advanced or Metastatic, Unresectable Sarcomas
Long Description: A Phase I Trial of CBT-1® in Combination with Doxorubicin in Patients with Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or less of Doxorubicin
MGH Status: Open
Sponsor: CBA Research, Inc.
Disease Program: Sarcoma

Next Steps


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Purpose

This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
Condition Title Intervention Phase
Sarcoma CBT-1® Phase 1
Study Type Interventional
Official Title A Phase I Trial of CBT-1® in Combination With Doxorubicin in Patients With Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or Less of Doxorubicin

Primary Outcome Measures

Maximum tolerated dose of CBT-1® when combined with doxorubicin [Time Frame: 3 years] [Designated as safety issue: ]


Secondary Outcome Measures

Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin [Time Frame: 3 years] [Designated as safety issue: ]

Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin [Time Frame: week 12] [Designated as safety issue: ]

Overall Response Rate [Time Frame: 3 years] [Designated as safety issue: ]

Estimated Enrollment: 46
Study Start Date: March 2018
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020

Eligibility

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

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Age ≥ 18 years
  • Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent
  • Measurable disease by RECIST 1.1
  • ECOG performance status of ≤ 1
  • Life expectancy of > 3 months
  • Able to swallow pills
  • Adequate bone marrow and organ function as defined as:
  • Hemoglobin > 9 g/dl
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Total bilirubin < 1.5 X ULN
  • AST(SGOT)/ALT(SGPT) ≤3 X ULN (including patients with liver metastases)
  • Creatinine <1.5 X ULN
  • Cardiac ejection fraction >50% (by echocardiogram or MUGA) within 15 days of enrollment
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
  • Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol.
  • Pre-menopausal women must have a negative pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant, double barrier and/or complete abstinence (non-periodic).
  • Washout period prior to Day 1 Cycle 1:
  • 3 weeks since last chemotherapy or therapeutic radiation therapy
  • 4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter
  • 2 weeks since any oral anti-neoplastic or oral investigational agent
  • Resolution of treatment-related toxicity to < grade 1; alopecia and cutaneous toxicity are allowed < grade 2
  • >1 week since palliative RT
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior exposure to CBT-1
  • Previously untreated sarcomas
  • Low-grade sarcomas as well as alveolar soft parts sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, gastrointestinal stromal tumor, chordoma
  • Participants receiving other investigational agents
  • Participants with known uncontrolled brain metastases
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic indwelling drains, history of interstitial pneumonitis or pulmonary fibrosis or psychiatric illness/social situations that would limit compliance with study requirements
  • Actively breastfeeding women unless it is interrupted during treatment and at least 6 weeks after treatment discontinuation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03002805

Locations

  • United States, California
    • Sarcoma Oncology Research Center Santa Monica, California, United States, 90403
  • United States, Florida
    • Mayo Clinic Jacksonville, Florida, United States, 32224
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Pennsylvania
    • University of Pittsburgh Medical Center Pittsburgh, Pennsylvania, United States, 15232
  • United States, Washington
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109

Sponsors and Collaborators

CBA Research

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03002805
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by CBA Research:

Phase I

CBT-1®

Doxorubicin

Sarcoma

Additional relevant MeSH terms:

Sarcoma

Doxorubicin

Liposomal doxorubicin

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