Recruiting

Phase 1

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

Sponsor:

CBA Research

Code:

NCT03002805

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT-1®

Study Details

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.

Conditions

Sarcoma

Study ID

NCT03002805

Start date

Mar 29, 2018

Status verified date

Aug, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Beth Gudeman

859-266-5757 bethg@cba-1.com

Beth Gudeman

859-227-0699 bethg@cba-1.com

Locations

Sarcoma Oncology Research Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Victoria Chua-Alcala

310-552-9999 vchua@sarcomaoncololgy.com

Principal Investigator:

Sant P. Chawla, M.D.

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Sherry Cook, RN

904-953-3321 cook.sherry1@mayo.edu

Principal Investigator:

Steven Attia, D.O.

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

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

Contacts

Research Nursing

617-632-5204

Principal Investigator:

Katherine Thornton, M.D.

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Melissa Burgess, M.D.

412-692-4724 burgessma@upmc.edu

Principal Investigator:

Melissa Burgess, M.D.

Seattle Cancer Care Alliance

Recruiting

Seattle, Washington, United States, 98109

Contacts

Roxanne Moore

206-606-6425 romoore@seattlecca.org

Principal Investigator:

Lee Cranmer, M.D.

More Information

Sponsor

CBA Research

Last update posted

Aug 19, 2019

Last verified

Aug, 2019

Keywords

Phase I
CBT-1®
Doxorubicin
Sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CBA Research on 2019-08-19.