A Phase 1 Study Evaluating CB-5083 in Patients With Relapsed/Refractory Multiple Myeloma
Conditions
Relapsed Multiple Myeloma - Refractory Multiple Myeloma - Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CB-5083 Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in relapsed/refractory multiple myeloma patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

Inclusion Criteria:

1. Males and females ≥18 years of age at the time of signing the consent form.

2. Must be able to adhere to the study visit schedule and other protocol requirements.

3. Have a documented diagnosis of MM according to International Myeloma Foundation (IMF) 2003 Criteria.

Dose Escalation phase:

• Patient has relapsed/refractory or refractory disease after receiving 2 or more lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (either in separate regimens or within the same regimen), and is ineligible for autologous hematopoietic stem cell transplantation.

Dose Expansion phase:

• Must have measurable disease.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.

5. Adequate bone marrow function documented within 72 hours prior to treatment without transfusion or growth factor support.

6. Adequate organ function.

7. Adequate cardiac function.

8. If a woman of childbearing potential (WOCBP), must have a negative serum β-hCG test within 3 days prior to Baseline. Note, no oral contraceptives allowed and must agree to use dual barrier contraceptive methods.

9. If male, agrees to use effective, dual barrier contraceptive methods (ie, a condom during any sexual contact with a WOCBP, with female partner using a barrier method) while on study drug and for 28 days afterward.

10. If male, agrees to refrain from donating sperm while on study drug and for 28 days after study discontinuation.

11. Willing and able to provide written Informed Consent.

12. All patients must agree not to share medication with another person.

Exclusion Criteria:

1. Diagnosis of nonsecretory or hyposecretory MM, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), plasma cell leukemia, Waldenström's macroglobulinemia, or amyloidosis.

2. Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4.

3. Use of any anti-myeloma drug therapy within 14 days prior to Baseline.

4. Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy.

5. Radiotherapy within 14 days prior to Baseline, any prior total body irradiation (TBI) or pelvic irradiation.

6. Major surgery within 6 weeks prior to Baseline. Patient must have recovered from surgery and be without current complications of infection or dehiscence.

7. Peripheral autologous stem cell transplant within 12 weeks prior to Baseline.

8. Patients who are eligible for autologous hematopoietic stem cell transplantation.

9. Patients with prior allogeneic transplants.

10. Active infection requiring systemic therapy.

11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness.

12. Cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 6 months prior to Baseline.

13. Acute pancreatitis or cholecystitis within 6 months prior to Baseline.

14. Gastrointestinal disease that may interfere with the absorption of orally-administered drugs.

15. Concomitant or expected use of any medication that alters stomach pH.

16. History of inflammatory bowel disease or other illness resulting in chronic diarrhea.

17. Known achlorhydria or history of gastrointestinal surgery that could reduce the acidity of the stomach.

18. Cirrhosis with severe liver dysfunction (Child-Pugh Class B or C).

19. Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors of cytochrome P450 (CYP) enzymes 2C9, 2C19, and 3A4 or are primarily metabolized by CYP 2C8 and 2C9. In addition, concomitant treatment with agents known to be substrates of the BCRP efflux pump is also excluded.

20. Use of any investigational agent within 28 days prior to Baseline.

21. Is a pregnant or lactating female.

22. Is a WOCBP, unless agreeing to use dual barrier contraceptive methods which, in the Investigator's opinion, are effective and adequate for that patient's circumstances while on study drug and for 3 months afterward.

23. Has any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of the study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
Locations
City of Hope National Medical Center
Duarte, California, United States
Status: Recruiting
Contact: Lupe Duarte - 626-256-4673 - lduarte@coh.org
University of California, San Francisco
San Francisco, California, United States
Status: Recruiting
Contact: Melody Billena - 415-476-9331 - BellinaM@cc.ucsf.edu
Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Kenisha Barron - kenisha.w.Barron@emory.edu
Washington University
St. Louis, Missouri, United States
Status: Recruiting
Contact: Brett Ramsey - 314-747-2844 - Baramsey@dom.wustl.edu
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Laura McBride, RN - 551-996-8704 - lmcbride@hackensackumc.org
Start Date
September 2014
Sponsors
Cleave Biosciences, Inc.
Source
Cleave Biosciences, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page