A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Fresenius Kabi Oncology Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fresenius Kabi Oncology Ltd.
Information provided by:
Fresenius Kabi Oncology Ltd.
ClinicalTrials.gov Identifier:
NCT00915369
First received: June 3, 2009
Last updated: February 5, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Breast Cancer |
Drug: Nanoxel (Paclitaxel Nanoparticle formulation ) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Fresenius Kabi Oncology Ltd.:
Primary Outcome Measures:
- The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
- Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
- Patients must be of 18-65 years of age (inclusive of both)
- Patients with ECOG performance status between 0 - 2
- Patients with at least one measurable lesion as per RECIST
Exclusion Criteria:
- Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.
- Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
- Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).
- Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915369
Contacts
| Contact: Shivakant Mishra, PhD | +91.120.4378604 | shivakant.mishra@fresenius-kabi.com |
| Contact: Amit Sharma, MD | +91.120.4378415 | amit_delhi.sharma@fresenius-kabi.com |
Locations
| India | |
| Nizam'S Institute of Medical Sciences | Recruiting |
| Hyderabaad, Andhra Pradesh, India | |
| Contact: D. Raghunadharao, DM +91.40.23372947 draghu_hyd@dataone.in | |
| Principal Investigator: D Raghunadharao, DM | |
| Kidwai Memorial Institute of Oncology | Recruiting |
| Bangalore, Karnataka, India | |
| Contact: Govind Babu +91.80.26579503 kgbtrials@yahoo.co.in | |
| Principal Investigator: Govind Babu, DM | |
| SEAROC Cancer Center, S K Soni Hospital | Recruiting |
| Jaipur, Rajasthan, India | |
| Contact: Anish Maru, DM +91-0141-2232409-11 ext 106 anishmaru@yahoo.com | |
| Principal Investigator: Anish Maru, DM | |
Sponsors and Collaborators
Fresenius Kabi Oncology Ltd.
More Information
No publications provided
| Responsible Party: | Dr. S. K. Mishra, Vice President - Clinical Research & Medical Services, Fresenius Kabi Oncology Ltd. |
| ClinicalTrials.gov Identifier: | NCT00915369 History of Changes |
| Other Study ID Numbers: | DO/NDR/02/2008/01 |
| Study First Received: | June 3, 2009 |
| Last Updated: | February 5, 2010 |
| Health Authority: | United States: Food and Drug Administration India: Drugs Controller General of India |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013