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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01427946

Enrollment

Registered

2011-09-02

Start date

2011-07-31

Completion date

2014-10-31

Last updated

2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

KRAS mutant, Non-Small Cell Lung Cancer, NSCLC

Brief summary

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).

Detailed description

This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and everolimus that can safely be given in combination. The Phase 2 portion of this study will continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with everolimus and compare the effect of the study drugs on tumor response and life expectancy in patients with KRAS mutant NSCLC.

Interventions

DRUGIPI-504

DRUGEverolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall Response Rate	Up to three years from last patient study visit	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

Measure	Time frame	Description
Progression Free Survival	Up to three years from last patient study visit	Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.
Time to Progression	Up to three years from last patient study visit	Time to progression (TTP), defined as time from study entry to progression.
Overall Survival	Up to three years from last patient study visit	Overall survival (OS), defined as time from study entry to death due to any cause, in patients with KRAS mutant NSCLC administered IPI-504 plus everolimus.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026