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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

October 23, 2008
April 10, 2013
August 2006
February 2014   (final data collection date for primary outcome measure)
There is no Primary Outcome [ Time Frame: No formal analysis of efficacy will occur ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00779428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin
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

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)
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Malignancies
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
Experimental: A1
Intervention: Drug: Tanespimycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00779428
CA200-002
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP