Clinical trial · Interventional
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
NCT00999401CI-TRIAL-00055634completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sapacitabine and seliciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sapacitabine and seliciclib
- description
- Sequential or concomitant administration of sapacitabine and seliciclib
- interventionNames
- Drug: sapacitabine and seliciclib
Primary outcomes (1)
- measure
- maximum tolerated dose
- timeFrame
- 1-3 months
- description
- MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
Secondary outcomes (2)
- measure
- tumor response rate
- timeFrame
- 1-3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTShapiro GI, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Cancer Res April 15, 2013 73; LB-202.