Advanced Solid Tumors
Conditions
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 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.
Interventions
DRUGsapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum tolerated dose | 1-3 months | MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tumor response rate | 1-3 months | Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors. |
| pharmacodynamic effects in skin and peripheral mononuclear cells | 1-3 months | PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors. |
Countries
United States
Outcome results
None listed