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

Primary Purpose

Advanced Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Nanoxel (Paclitaxel Nanoparticle formulation )
Sponsored by
Fresenius Kabi Oncology Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Nizam'S Institute of Medical SciencesRecruiting
  • Kidwai Memorial Institute of OncologyRecruiting
  • SEAROC Cancer Center, S K Soni HospitalRecruiting

Outcomes

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

Secondary Outcome Measures

evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.

Full Information

First Posted
June 3, 2009
Last Updated
February 5, 2010
Sponsor
Fresenius Kabi Oncology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00915369
Brief Title
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
Official Title
A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fresenius Kabi Oncology Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nanoxel (Paclitaxel Nanoparticle formulation )
Intervention Description
Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.
Time Frame
Throughout the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivakant Mishra, PhD
Phone
+91.120.4378604
Email
shivakant.mishra@fresenius-kabi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Sharma, MD
Phone
+91.120.4378415
Email
amit_delhi.sharma@fresenius-kabi.com
Facility Information:
Facility Name
Nizam'S Institute of Medical Sciences
City
Hyderabaad
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D. Raghunadharao, DM
Phone
+91.40.23372947
Email
draghu_hyd@dataone.in
First Name & Middle Initial & Last Name & Degree
D Raghunadharao, DM
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
State/Province
Karnataka
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Govind Babu
Phone
+91.80.26579503
Email
kgbtrials@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Govind Babu, DM
Facility Name
SEAROC Cancer Center, S K Soni Hospital
City
Jaipur
State/Province
Rajasthan
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Maru, DM
Phone
+91-0141-2232409-11
Ext
106
Email
anishmaru@yahoo.com
First Name & Middle Initial & Last Name & Degree
Anish Maru, DM

12. IPD Sharing Statement

Learn more about this trial

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

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