A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT00999401
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-271
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. The secondary objectives are to evaluate antitumor activity of this sequential treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI:
Eunice Kwak, MD,
Massachusetts General Hospital
Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
linda_pointon@dfci.harvard.edu
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
Inclusion Criteria:
- Incurable advanced solid tumors that are no longer responding to conventional therapy
or for which no effective therapy exists
- 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