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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915369
Recruitment Status : Unknown
Verified February 2010 by Fresenius Kabi Oncology Ltd..
Recruitment status was:  Recruiting
First Posted : June 8, 2009
Last Update Posted : February 8, 2010
Information provided by:
Fresenius Kabi Oncology Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Nanoxel (Paclitaxel Nanoparticle formulation ) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer
Study Start Date : March 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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.

Primary Outcome Measures :
  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 [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc. [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00915369

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Contact: Shivakant Mishra, PhD +91.120.4378604
Contact: Amit Sharma, MD +91.120.4378415

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Nizam'S Institute of Medical Sciences Recruiting
Hyderabaad, Andhra Pradesh, India
Contact: D. Raghunadharao, DM    +91.40.23372947   
Principal Investigator: D Raghunadharao, DM         
Kidwai Memorial Institute of Oncology Recruiting
Bangalore, Karnataka, India
Contact: Govind Babu    +91.80.26579503   
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   
Principal Investigator: Anish Maru, DM         
Sponsors and Collaborators
Fresenius Kabi Oncology Ltd.
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Responsible Party: Dr. S. K. Mishra, Vice President - Clinical Research & Medical Services, Fresenius Kabi Oncology Ltd. Identifier: NCT00915369    
Other Study ID Numbers: DO/NDR/02/2008/01
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action