Clinical trial · Interventional
Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies
Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
NCT00329329CI-TRIAL-00006573terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to discontinue study drug development
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.
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 |
|---|---|---|---|
| Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| satraplatin and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MTD
- timeFrame
- 2007
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- 2007
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective * Age \> 18 years old * ECOG Performance Status \< 2 * Female patients may not be pregnant or lactating and must be willing to practice contraception * Adequate organ function as defined by the following: * Serum creatinine \< 1.5 mg/dl * Absolute neutrophil count (ANC) \> 1500/dL * Platelets \> 100,000/dL * Total bilirubin \< upper limit of normal (ULN) for the reference lab * AST, ALT, and alkaline phosphatase must be within the designated range allowing for eligibility Key Exclusion Criteria: * Other chemotherapy treatment \< 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent \< 3 months from time of enrollment * Radiotherapy involving \> 30% of the active bone marrow * Radiotherapy \< 4 weeks prior to enrollment * Pre-existing peripheral neuropathy \> grade 1 * Pre-existing hearing loss \> grade 2 * Metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper * Patients who have not recovered (\> grade 1) from the following toxicities of previous regimens before enrollment: * hematologic toxicities * fatigue * mucositis * nausea/vomiting * diarrhea * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements * History of hypersensitivity reaction to capecitabine, 5-FU or any platinum containing drugs * History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness * Evidence of concurrent second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ * Concurrent use of medications that inhibit cytochrome P450 3A4 (including aprepitant) * History of bone marrow or major organ transplant
References
Publications (0)
Data not yet available
No reference posted for this study.