Clinical trial · Interventional
Geldanamycin Analogue in Treating Patients With Advanced Cancer
A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies
NCT00003969CI-TRIAL-00011114completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks
Secondary outcomes (2)
- measure
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment
- measure
- Pharmacokinetic profile of 17-AAG during the first course of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * 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 Hepatic: * 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 Renal: * Creatinine less than 1.47 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * 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% Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * 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 Radiotherapy: * At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered * Concurrent radiotherapy allowed for control of bone pain or as indicated Surgery: * Not specified Other: * No other concurrent investigational treatment * No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)
References
Publications (1)
- RESULTBanerji U, O'Donnell A, Scurr M, Pacey S, Stapleton S, Asad Y, Simmons L, Maloney A, Raynaud F, Campbell M, Walton M, Lakhani S, Kaye S, Workman P, Judson I. Phase I pharmacokinetic and pharmacodynamic study of 17-allylamino, 17-demethoxygeldanamycin in patients with advanced malignancies. J Clin Oncol. 2005 Jun 20;23(18):4152-61. doi: 10.1200/JCO.2005.00.612. PMID 15961763