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
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
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
More Information
No publications provided
Responsible Party: |
Sponsor
|
ClinicalTrials.gov Identifier: |
NCT03002805 |
Other Study ID Numbers: |
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Study First Received: |
|
Last Updated: |
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Health Authority: |
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Keywords provided by CBA Research:
Phase I
CBT-1®
Doxorubicin
Sarcoma
Additional relevant MeSH terms:
Sarcoma
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 January 20, 2021