Status:
COMPLETED
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Lead Sponsor:
Cyclacel Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
Detailed Description
The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The second...
Eligibility Criteria
Inclusion
- Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
- Age 18 years or older
- ECOG 0-2
- Life expectancy ≥ 3 months
- Evaluable disease
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- Able to swallow capsules
- At least 3 weeks from major surgery
- Agree to practice effective contraception
- Ability to understand and willingness to sign the informed consent form
Exclusion
- Previously untreated CNS metastases or progressive CNS metastases
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including
- Pregnant or lactating women
- Known to be HIV-positive
- A history of active hepatitis B and/or hepatitis C infection
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00999401
Start Date
April 1 2009
End Date
August 13 2019
Last Update
December 22 2021
Active Locations (2)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215