Clinical trial · Interventional
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
NCT02597465CI-TRIAL-00048821withdrawnPhase 3ClinicalTrials.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 not to initiate the study for alternate commercial strategy
Summary
Brief summary (as posted)
An open label study to determine the efficacy and safety of SPARC1507
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 Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reference1507 | Drug | — | UNRESOLVED |
| SPARC1507 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARC1507
- description
- SPARC1507
- interventionNames
- Drug: SPARC1507
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Chemotherapy
- interventionNames
- Drug: Reference1507
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
- timeFrame
- 3 years and 6 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of advanced/metastatic biliary tract cancer * Male or female ≥ 18 years old * Participants must have measurable disease according to RECIST * ECOG performance status ≤ 1 Exclusion Criteria: * Known hypersensitivity to trial treatments, or their excipients * Prior history of treatment with any taxane therapy * Cardiovascular disorders as per Investigator's discretion * The subject has received radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.