A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer

NCT00915369 | Unknown Phase 1

• 1 other identifier: DO/NDR/02/2008/01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Throughout the study

Secondary Outcomes (1)

• evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.

  Throughout the study

Interventions

Nanoxel (Paclitaxel Nanoparticle formulation ) DRUG

Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fresenius Kabi Oncology Ltd.: lead

Study Sites (3)

Nizam'S Institute of Medical Sciences

Hyderabaad, Andhra Pradesh, India

RECRUITING

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

RECRUITING

SEAROC Cancer Center, S K Soni Hospital

Jaipur, Rajasthan, India

RECRUITING

Central Study Contacts

Shivakant Mishra, PhD

CONTACT

+91.120.4378604; shivakant.mishra@fresenius-kabi.com

Amit Sharma, MD

CONTACT

+91.120.4378415; amit_delhi.sharma@fresenius-kabi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 8, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 8, 2010

Record last verified: 2010-02

Locations

IN (3)