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NCT Number: NCT01427946

Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Voluntarily sign an informed consent form (ICF).
  • Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
  • Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
  • Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
  • ECOG performance of 0-1.

Exclusion criteria

  • Prior treatment with IPI-504 or other Hsp90 inhibitors.
  • Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
  • Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
  • Inadequate hematologic function defined as:
  • Inadequate hepatic function defined by:
  • Inadequate renal function defined by serum creatinine >1.5 x ULN.

Treatment and study plan

IPI-504

Drug

Other names: retaspimycin hydrochloride

Everolimus

Drug

Other names: Afinitor

Primary outcomes

  1. Overall Response Rate

    Time frame: 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 outcomes

  1. Progression Free Survival

    Time frame: 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.

  2. Time to Progression

    Time frame: Up to three years from last patient study visit

    Time to progression (TTP), defined as time from study entry to progression.

  3. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Infinity Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2011
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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