Trials / Unknown
UnknownNCT00915369
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Fresenius Kabi Oncology Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nanoxel (Paclitaxel Nanoparticle formulation ) | Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2009-06-08
- Last updated
- 2010-02-08
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00915369. Inclusion in this directory is not an endorsement.