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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002805
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
CBA Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: CBT-1® Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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

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

Secondary Outcome Measures :
  1. Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin [ Time Frame: 3 years ]
  2. 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

  3. Overall Response Rate [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Correlation of DCR, ORR and PFS to disease subtype [ Time Frame: 3 years ]
  2. Correlation of P-gp expression at baseline to P-gp expression after treatment [ Time Frame: 3 years ]
  3. Correlation of tumor response to P-gp inhibition by CBT-1® [ Time Frame: 3 years ]
  4. Presence of CBT-1® in tumor tissue [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Beth Gudeman 859-266-5757 bethg@cba-1.com
Contact: Beth Gudeman 859-227-0699 bethg@cba-1.com

Locations
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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.         
Sponsors and Collaborators
CBA Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CBA Research:
Phase I
CBT-1®
Doxorubicin
Sarcoma
Additional relevant MeSH terms:
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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