CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
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ClinicalTrials.gov Identifier: NCT03002805 |
Recruitment Status : Unknown
Verified August 2019 by CBA Research.
Recruitment status was: Recruiting
First Posted : December 26, 2016
Last Update Posted : August 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: CBT-1® | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 29, 2018 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |

- Drug: 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 Name: doxorubicin
- Maximum tolerated dose of CBT-1® when combined with doxorubicin [ Time Frame: 3 years ]
- Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin [ Time Frame: 3 years ]
- Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin [ Time Frame: week 12 ]DCR = Overall Response Rate [ORR = Complete Response + Partial Response] + Stable Disease by RECIST 1.1
- Overall Response Rate [ Time Frame: 3 years ]
- Correlation of DCR, ORR and PFS to disease subtype [ Time Frame: 3 years ]
- Correlation of P-gp expression at baseline to P-gp expression after treatment [ Time Frame: 3 years ]
- Correlation of tumor response to P-gp inhibition by CBT-1® [ Time Frame: 3 years ]
- Presence of CBT-1® in tumor tissue [ Time Frame: 3 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002805
Contact: Beth Gudeman | 859-266-5757 | bethg@cba-1.com | |
Contact: Beth Gudeman | 859-227-0699 | bethg@cba-1.com |
United States, California | |
Sarcoma Oncology Research Center | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Victoria Chua-Alcala 310-552-9999 vchua@sarcomaoncololgy.com | |
Principal Investigator: Sant P. Chawla, M.D. | |
United States, Florida | |
Mayo Clinic | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Sherry Cook, RN 904-953-3321 cook.sherry1@mayo.edu | |
Principal Investigator: Steven Attia, D.O. | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Barbara Anderson, RN 617-643-2427 banderson15@partners.org | |
Principal Investigator: Gregory Cote, M.D., Ph.D. | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Research Nursing 617-632-5204 | |
Principal Investigator: Katherine Thornton, M.D. | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Melissa Burgess, M.D. 412-692-4724 burgessma@upmc.edu | |
Principal Investigator: Melissa Burgess, M.D. | |
United States, Washington | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Roxanne Moore 206-606-6425 romoore@seattlecca.org | |
Principal Investigator: Lee Cranmer, M.D. |
Responsible Party: | CBA Research |
ClinicalTrials.gov Identifier: | NCT03002805 |
Other Study ID Numbers: |
STS-1701 |
First Posted: | December 26, 2016 Key Record Dates |
Last Update Posted: | August 19, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Phase I CBT-1® Doxorubicin Sarcoma |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Antibiotics, Antineoplastic |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |