NCT01427946

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

August 31, 2011

Last Update Submit

November 12, 2014

Conditions

Non-small Cell Lung Cancer

Keywords

KRAS mutantNon-Small Cell Lung CancerNSCLC

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    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).

    Up to three years from last patient study visit

Secondary Outcomes (3)

  • Progression Free Survival

    Up to three years from last patient study visit

  • Time to Progression

    Up to three years from last patient study visit

  • Overall Survival

    Up to three years from last patient study visit

Study Arms (1)

Retaspimycin HCl (IPI-504) and Everolimus

EXPERIMENTAL

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.

Drug: IPI-504Drug: Everolimus

Interventions

IPI-504DRUG
Also known as: retaspimycin hydrochloride
Retaspimycin HCl (IPI-504) and Everolimus
EverolimusDRUG
Also known as: Afinitor
Retaspimycin HCl (IPI-504) and Everolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tanespimycinEverolimus

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Tess Schmalbach, MD, PhD

    Infinity Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 2, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

US(5)