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Geldanamycin Analogue in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003969
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: tanespimycin Phase 1

Detailed Description:


  • Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.
  • Determine the toxic effects and dose-limiting toxicity of AAG in this patient population.
  • Determine the safe dose of AAG for a Phase II study.
  • Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.
  • Assess time to tumor progression and any antitumor activity in patients treated with AAG.

OUTLINE: This is a dose-escalation study.

Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV over 15-30 minutes every week. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies
Study Start Date : August 1998
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks

Secondary Outcome Measures :
  1. Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment
  2. Pharmacokinetic profile of 17-AAG during the first course of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists
  • Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent



  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL
  • Absolute neutrophil count at least 1,500/mm^3


  • Bilirubin less than 1.0 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases
  • No chronic liver disease


  • Creatinine less than 1.47 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No myocardial infarction within the past 6 months
  • No angina requiring treatment within the past 6 months
  • No uncompensated coronary artery disease by electrocardiogram or physical examination
  • No prior transient ischemic attacks, stroke, or peripheral vascular disease
  • LVEF at least 45%


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No allergy to egg products
  • No nonmalignant systemic disease that would increase risk
  • No active uncontrolled infection
  • No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since other prior endocrine therapy and recovered
  • Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study


  • At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
  • Concurrent radiotherapy allowed for control of bone pain or as indicated


  • Not specified


  • No other concurrent investigational treatment
  • No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003969

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United Kingdom
Royal Marsden NHS Foundation Trust - London
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Cancer Research UK
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Study Chair: Ian R. Judson, MA, MD, FRCP Royal Marsden NHS Foundation Trust
Publications of Results:
Layout table for additonal information Identifier: NCT00003969    
Other Study ID Numbers: CRC-PHASE-I-PH1/074
CDR0000067170 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: December 2000
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific