Clinical trial · Interventional
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
NCT01304303CI-TRIAL-00038430completedPhase 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)
Phase I study of SPARC1023 alone and in combination with carboplatin
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 |
|---|---|---|---|
| Solid Tumor in Advanced Stage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPARC1023 I | Drug | — | UNRESOLVED |
| SPARC1023 II | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARC1023 I
- interventionNames
- Drug: SPARC1023 I
- type
- EXPERIMENTAL
- label
- SPARC1023 II
- interventionNames
- Drug: SPARC1023 II
Primary outcomes (1)
- measure
- Determination of MTD
- timeFrame
- One 21-day treatment cycle
- description
- MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * ECOG Performance Status ≤ 1. * Estimated life expectancy of at least 12-weeks; * Measurable disease as per RECIST guideline (Version 1.1); Exclusion Criteria: * Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer * Known hypersensitivity to the study drugs * Treatment with any anti-cancer agents within 28 days of study entry * Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.