Trials / Withdrawn
WithdrawnNCT04332549
To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects With Locally Recurrent or Metastatic Breast Cancer.
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PICS (Reconstitution Method 1 or 2) | dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS |
Timeline
- Start date
- 2020-04-27
- Primary completion
- 2021-01-28
- Completion
- 2021-01-28
- First posted
- 2020-04-02
- Last updated
- 2020-06-01
Locations
22 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04332549. Inclusion in this directory is not an endorsement.