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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignancies

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

There is no Primary Outcome

Outcome Time Frame:

No formal analysis of efficacy will occur

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA200-002

NCT ID:

NCT00779428

Start Date:

August 2006

Completion Date:

February 2014

Related Keywords:

  • Advanced Malignancies
  • This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin
  • Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Local InstitutionDuncansville, Pennsylvania