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
Information provided by:
Fresenius Kabi Oncology Ltd.
ClinicalTrials.gov Identifier:
First received: June 3, 2009
Last updated: February 5, 2010
Last verified: February 2010
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:

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915369

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

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

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
Breast Diseases
Neoplasms by Site
Skin Diseases
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 26, 2016