CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
NCT ID: NCT03002805
Last Updated: 2019-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
46 participants
INTERVENTIONAL
2018-03-29
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CBT-1®
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CBA Research
INDUSTRY
Responsible Party
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Locations
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Sarcoma Oncology Research Center
Santa Monica, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Research Nursing
Role: primary
References
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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.
Other Identifiers
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STS-1701
Identifier Type: -
Identifier Source: org_study_id
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