Clinical trial · Interventional
Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)
A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Either Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) or Advanced or Metastatic Soft Tissue Sarcomas (STS)
NCT00276302CI-TRIAL-00004257completedPhase 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)
The primary objectives of the study are: * Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies * Recommend a dose for subsequent studies of IPI-504
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPI-504 | Drug | Retaspimycin Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Schedule A: Doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration.
- interventionNames
- Drug: IPI-504
- type
- EXPERIMENTAL
- label
- 2
- description
- Schedule B: Doses occur on Days 1, 4, 8, 11, 15, and 18 (twice weekly for 3 weeks continuously).
- interventionNames
- Drug: IPI-504
Primary outcomes (2)
- measure
- To determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed diagnosis of GIST or STS * Failed prior therapies * ECOG performance status of 0-2 * Ability to adhere to the study visit schedule and all protocol requirements Exclusion Criteria: * Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor * Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment * Concurrent radiation therapy is not permitted * Concurrent treatment with any agent that alters CYP3A activity * Concurrent treatment with any agent that may prolong the QTc interval * Myocardial infarction or active ischemic heart disease within 6 months * History of arrhythmia * Baseline QTc \>450 * Grade 3 or greater peripheral neuropathy * Renal insufficiency, serum creatinine \>1.5 x ULN * Platelets \< 100,000 mm3 * AST and / or ALT \> 2.5 x ULN * ANC \<1,500 cells/mm3 * Alkaline phosphatase \> 2.5 x ULN * Amylase and lipase \> 1.5 x ULN * Hemoglobin \< 9.0 g/dL
References
Publications (0)
Data not yet available
No reference posted for this study.