Clinical trial · Interventional
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
NCT03109249CI-TRIAL-00038440completedPhase 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)
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.
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 |
|---|---|---|---|
| Recurrent or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reference1613 | Drug | — | UNRESOLVED |
| SPARC1613 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARC1613
- description
- Intravenous administration of SPARC1613
- interventionNames
- Drug: Reference1613
- type
- ACTIVE_COMPARATOR
- label
- Reference 1613
- description
- Intravenous administration of Reference1613
- interventionNames
- Drug: SPARC1613
Primary outcomes (1)
- measure
- Maximum observed concentration (Cmax)
- timeFrame
- Pre-dose,post dose upto 3 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has given written, informed consent and is available for the duration of study * Histologically or cytologically confirmed diagnosis of breast cancer * Male or female aged ≥ 18 years * Females subjects of child-bearing potential must have a negative urine pregnancy test * Female subjects must be non-lactating and non-breastfeeding * Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing Exclusion Criteria: * Known hypersensitivity to either of the study drugs or their excipients * Inability to undergo venipuncture and/or tolerate venous access * Pre-existing clinically significant peripheral neuropathy * Positive laboratory exclusion test (HIV, HBsAg, or HCV) * Treatment with investigational agents or participation in clinical trial within 30 days of study entry
References
Publications (0)
Data not yet available
No reference posted for this study.