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 secondary objectives are to evaluate antitumor activity of this sequential
or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin
and peripheral blood mononuclear cells.
Title
- Brief Title: A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
- Official Title: A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CYC682-07
- NCT ID:
NCT00999401
Conditions
Interventions
Drug | Synonyms | Arms |
---|
sapacitabine and seliciclib | | sapacitabine and seliciclib |
Purpose
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 secondary objectives are to evaluate antitumor activity of this sequential
or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin
and peripheral blood mononuclear cells.
Trial Arms
Name | Type | Description | Interventions |
---|
sapacitabine and seliciclib | Experimental | Sequential or concomitant administration of sapacitabine and seliciclib | - sapacitabine and seliciclib
|
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | maximum tolerated dose |
Time Frame: | 1-3 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | tumor response rate |
Time Frame: | 1-3 months |
Safety Issue: | |
Description: | |
Measure: | pharmacodynamic effects in skin and peripheral mononuclear cells |
Time Frame: | 1-3 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
Last Updated
May 3, 2016