CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
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
1 other identifier
interventional
46
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2018
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
December 26, 2016
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 19, 2019
August 1, 2019
2.4 years
December 15, 2016
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of CBT-1® when combined with doxorubicin
3 years
Secondary Outcomes (3)
Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin
3 years
Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin
week 12
Overall Response Rate
3 years
Other Outcomes (4)
Correlation of DCR, ORR and PFS to disease subtype
3 years
Correlation of P-gp expression at baseline to P-gp expression after treatment
3 years
Correlation of tumor response to P-gp inhibition by CBT-1®
3 years
- +1 more other outcomes
Interventions
CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®: Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed.
Eligibility Criteria
You may qualify if:
- 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.
- +9 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CBA Researchlead
Study Sites (6)
Sarcoma Oncology Research Center
Santa Monica, California, 90403, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Related Publications (1)
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
PMID: 31401903DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2016
First Posted
December 26, 2016
Study Start
March 29, 2018
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
August 19, 2019
Record last verified: 2019-08