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A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer (IXAMPLE2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00883116
First received: April 16, 2009
Last updated: March 28, 2013
Last verified: July 2012
History of Changes
  Purpose

The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as measured by overall survival compared to standard chemotherapy (Paclitaxel or Doxorubicin) in women with advanced endometrial cancer that progressed after first line chemotherapy


Condition Intervention Phase
Endometrial Cancer
 Drug: Ixabepilone
Drug: Doxorubicin
Drug: Paclitaxel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Evidence of improved overall survival (OS) with ixabepilone versus control chemotherapy (paclitaxel or doxorubicin) as reported per Investigator [ Time Frame: Upon death for each patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the PFS in randomized subjects with measurable disease [ Time Frame: After all required death events have occurred for final database lock ] [ Designated as safety issue: No ]
  • Comparison of the objective response rate (ORR) of ixabepilone versus control chemotherapy in subjects with measurable disease [ Time Frame: After all required death events have occurred for final database lock ] [ Designated as safety issue: No ]
  • Estimation of the duration of response and time to response of ixabepilone versus control chemotherapy, in responding subjects with measurable disease [ Time Frame: After all required death events have occurred for final database lock ] [ Designated as safety issue: No ]
  • Evaluation of the toxicity profiles of ixabepilone and control chemotherapy [ Time Frame: After all required death events have occurred for final database lock ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone Drug: Ixabepilone
Injection, IV, 40 mg/m², Once every 21 days, Until progression or unacceptable toxicity
Other Names:
  • Ixempra
  • BMS-247550
Active Comparator: Control Chemotherapy
Doxorubicin or Paclitaxel
 Drug: Doxorubicin
Injection, IV injection, 60 mg/m², Once every 21 days, Until progression, unacceptable toxicity or cumulative dose of 500 mg/m²
Other Names:
  • Adriamycin PFS/RDF
  • Adriacin
  • Adriblastina
  • Adriablastine
  • Adrimedac
  • DOXO-CELL
  • Doxolem
  • Doxorubin
  • Farmiblastina
  • Rubex
Drug: Paclitaxel
Injection, IV, 175 mg/m², Once every 21 days, Until progression or unacceptable toxicity
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol Praxel
  • Taxol Konzentrat
  • F1-106

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial cancer, locally advanced, recurrent or metastatic
  • Karnofsky performance status (KPS) ≥ 70
  • Measurable or non-measurable disease that has progressed since last treatment
  • Receipt of prior platinum based chemotherapy regimen for advanced endometrial cancer
  • Subjects may have received 2 prior chemotherapy (ie. cytotoxic) regimens if 1 regimen was given for Stage I or II disease
  • Women, ages 18 to older

Exclusion Criteria:

  • Carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas
  • No prior first-line chemotherapy or receipt of ≥ 2 prior chemotherapy regimens except as defined in the Inclusion Criteria
  • Known brain metastases
  • Prior ixabepilone therapy
  • Concurrent active infection requiring antibiotics or other therapy
  • Concurrent unstable disease or illness that could jeopardize participation in study
  • Impaired cardiac function with LVEF of < 50% as measured by MUGA or ECHO
  • Malignancy within last 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or of the breast not treated with chemotherapy
  • Grade ≥ 2 neuropathy (sensory or motor)
  • Inadequate hematologic, renal and hepatic function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883116

  Show 49 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00883116     History of Changes
Other Study ID Numbers: CA163-196, 2008-007167-16
Study First Received: April 16, 2009
Last Updated: March 28, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Norway: Directorate of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
 Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial
Doxorubicin
Paclitaxel
Epothilones
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013