Clinical trial · Interventional
Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC
NCT01427946CI-TRIAL-00016055completedPhase 1 / Phase 2ClinicalTrials.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)
Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung Cancer (NSCLC).
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| IPI-504 | Drug | Retaspimycin Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Retaspimycin HCl (IPI-504) and Everolimus
- description
- Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs.
- interventionNames
- Drug: IPI-504
- Drug: Everolimus
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to three years from last patient study visit
- description
- Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Secondary outcomes (3)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years of age 2. Voluntarily sign an informed consent form (ICF). 3. Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV 4. Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy 5. Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen. 6. ECOG performance of 0-1. Exclusion Criteria: 1. Prior treatment with IPI-504 or other Hsp90 inhibitors. 2. Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors. 3. Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia. 4. Inadequate hematologic function defined as: 5. Inadequate hepatic function defined by: 6. Inadequate renal function defined by serum creatinine \>1.5 x ULN.
References
Publications (0)
Data not yet available
No reference posted for this study.