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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00779428
First received: October 23, 2008
Last updated: May 5, 2014
Last verified: May 2014
  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:


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: July 2006
Study Completion Date: July 2013
Primary Completion Date: March 2013 (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
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: NCT00779428

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

Additional Information:
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: May 5, 2014
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 August 28, 2014