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Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00779428
First received: October 23, 2008
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)


Condition Intervention Phase
Advanced Malignancies
 Drug: Tanespimycin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • There is no Primary Outcome [ Time Frame: No formal analysis of efficacy will occur ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2006
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Tanespimycin

Solution, IV

This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)

Other Name: BMS-722782

  Eligibility

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

Inclusion Criteria:

  • Age >= 18 years
  • Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol
  • All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor
  • All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2
  • The following laboratory results, within 10 days of Tanespimycin administration:
  • Hemoglobin >= 8 g/dL
  • Absolute neutrophils count >= 1.0x 10*9* /L
  • Platelet count >= 50 x 10*9* /L
  • Serum bilirubin <= 2 x ULN
  • AST <= 2.5 ULN
  • Serum creatinine <= 2 x ULN
  • ECOG performance status of 0, 1 or 2
  • Signed informed consent

Exclusion Criteria:

  • Pre-existing neuropathy of CTCAE Grade >= 3 due to any cause
  • Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)
  • Pregnant or breast-feeding women
  • Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication
  • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779428

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  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: NCT00779428     History of Changes
Other Study ID Numbers: CA200-002
Study First Received: October 23, 2008
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013