Clinical trial · Interventional
Pharmacokinetic, Safety and Tolerability Study of SPARC1028
NCT01305512CI-TRIAL-00038434completedPhase 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)
Evaluation of pharmacokinetic profile of SPARC1028
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPARC1028 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPARC1028
- interventionNames
- Drug: SPARC1028
Primary outcomes (1)
- measure
- Determination of Maximum Tolerated Dose (MTD) during dose escalation
- timeFrame
- One 21-day treatment cycle
- description
- MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
Secondary outcomes (1)
- measure
- Establishing pharmacokinectic profile at each dose level for SPARC1028
- timeFrame
- One 21-day treatment cycle
- description
- Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option. * Age ≥18 years * ECOG Performance Status ≤ 1. * Estimated life expectancy of at least 12-weeks; 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.