Clinical trial · Interventional
17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery
A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors
NCT00248521CI-TRIAL-00011573unknownPhase 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, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.
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 |
|---|---|---|---|
| alvespimycin hydrochloride | Drug | Alvespimycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
Secondary outcomes (3)
- measure
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
- measure
- Tumor response by RECIST criteria every 6 weeks while on study
- measure
- Clinical pharmacokinetic profile established during the first course of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor * Unresectable or metastatic disease * Standard curative or palliative measures do not exist OR are no longer effective OR patient refused such measures * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 12 weeks Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal * No chronic liver disease * Hepatitis B or C negative Renal * Creatinine normal OR * Creatinine clearance normal Cardiovascular * No symptomatic New York Heart Association class III-IV cardiac disease * No myocardial infarction within the past year * No active ischemic heart disease within the past year * No poorly controlled angina * No uncontrolled dysrhythmia or dysrhythmias requiring antiarrhythmic drugs * No transient ischemic attack * No stroke * No peripheral vascular disease * No congenital long QT syndrome * No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * QTc \< 450 msec (for men) and 470 msec (for woman) * LVEF \> 40% by MUGA * No left bundle branch block Pulmonary * No symptomatic pulmonary disease requiring medication, including any of the following: * Dyspnea with or without exertion * Paroxysmal nocturnal dyspnea * Oxygen requirement * Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 4 weeks before, during, and for 6 months after completion of study treatment * No known HIV positivity * No other malignancy within the past 5 years except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No ongoing or active infection * No diabetes mellitus (with evidence of severe peripheral vascular disease or ulcers) * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * Concurrent epoetin alfa allowed Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) Endocrine therapy * More than 4 weeks since prior endocrine therapy * Concurrent luteinizing hormone-releasing hormone analogues for androgen-insensitive prostate cancer and rising prostate-specific antigen allowed Radiotherapy * More than 4 weeks since prior radiotherapy (except for palliative treatment) * No prior irradiation field that potentially included the heart (e.g., mantle) Surgery * Not specified Other * Recovered from all prior therapy * Concurrent bisphosphonates allowed * At least 5 half-lives since prior and no concurrent medication that prolong QTc * No other concurrent anticancer or investigational agents * No concurrent grapefruit juice
References
Publications (1)
- RESULTPacey SC, Wilson RH, Walton M, et al.: A phase I trial of the heat shock protein 90 (HSP90) inhibitor alvespimycin (17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG) administered weekly, intravenously, to patients with advanced solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-PR-6, 2007.