Clinical trial · Interventional
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
NCT02136927CI-TRIAL-00038438terminatedPhase 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)
Pharmacokinetic, bioequivalence study
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reference1210 | Drug | — | UNRESOLVED |
| SPARC1210 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARC1210
- description
- Intravenous administration of SPARC1210
- interventionNames
- Drug: SPARC1210
- type
- ACTIVE_COMPARATOR
- label
- Reference1210
- description
- Intravenous administration of Reference1210
- interventionNames
- Drug: Reference1210
Primary outcomes (1)
- measure
- Maximum observed concentration (Cmax)
- timeFrame
- Pre-dose, post-dose up to 3 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has given written, informed consent and is available for the entire study. * Histologically or cytologically confirmed diagnosis of breast cancer; * Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option; * Age 18 years or more Exclusion Criteria: * Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); * Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; * Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0); * Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
References
Publications (0)
Data not yet available
No reference posted for this study.