A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362400
• Other study ID #: IPI 504-14
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2011
• Last updated: May 16, 2014
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer

Description:

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be =18 years of age

• Voluntarily signed an informed consent

• Confirmed NSCLC and Stage IIIB or IV disease.

• At least a =15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.

• Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy

• Must have experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.

• Must have received no more than 2 prior chemotherapy regimens

• Measurable disease by RECIST 1.1 criteria.

• ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).

• Women of child-bearing potential (WCBP), all sexually active male patients, and partners of patients must agree to use adequate methods of birth control.

Exclusion Criteria:

• Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment

• Known hypersensitivity to drugs formulated with polysorbate-80.

• Not recovered from any toxicities related to prior treatment

• Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer

• Inadequate hematologic function

• Inadequate hepatic function

• Inadequate renal function

• Symptomatic keratitis or keratoconjunctivitis.

• Uncontrolled systemic fungal, bacterial, viral or other infection

• Patients with clinically active brain metastases

• Patients with clinically stable brain metastases (previously treated or untreated) are eligible.

• Sinus bradycardia (resting heart rate <50 bpm).

• Significant cardiac disease

• Previous or current malignancies at other sites within the last 2 years

• Prior hepatic resections or hepatic-directed therapy

• Known HIV-positive patients receiving combination antiretroviral therapy.

• Women who are pregnant or lactating.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• IPI 504 plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
• Placebo plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)

Locations

Country	Name	City	State
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Pándy Kálmán Megyei Kórház	Gyula	Bekes
Hungary	Mátrai Gyógyintézet	Mátraháza	Heves
Hungary	Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza	Sopron	Gyor-moson-sopron
Hungary	Zala Megyei Kórház	Zalaegerszeg	Zala
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do
Korea, Republic of	Inha University Hospital	Jung Gu	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Severance Hospital,Yonsei University Health System	Seoul
Romania	Spitalul de Urgenta "Constantin Opris"	Baia Mare	Maramures
Romania	Institutul Oncologic "Prof. Dr. I. Chiricuta"	Cluj-Napoca	Cluj
Romania	Spitalul Municipal Ploiesti	Ploiesti	Prahova
Romania	Spitalul Clinic Judetean de Urgenta Sibiu	Sibiu
Russian Federation	State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"	Chelaybinsk
Russian Federation	Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology	Moscow
Russian Federation	Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"	Moscow
Russian Federation	City Oncology Hospital # 62	Moscow Region	Moscow
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
United States	Ann Arbor Hematology Oncology Associates	Ann Arbor	Michigan
United States	Texas Oncology-Arlington South	Arlington	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Central Indiana Cancer Centers	Carmel	Indiana
United States	Ironwood Cancer and Research Center	Chandler	Arizona
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Blumenthal Cancer Center	Charlotte	North Carolina
United States	Chattanooga Oncology and Hematology Associates, PC	Chattanooga	Tennessee
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Puget Sound Cancer Centers	Edmonds	Washington
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Broome Oncology, LLC	Johnson City	New York
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Owsley Brown Frazier Cancer Center-Louisville Downtown	Louisville	Kentucky
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Indiana University Health Ball Memorial Hospital	Muncie	Indiana
United States	Community Hospital	Munster	Indiana
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Floyd Memorial Cancer Center of Indiana	New Albany	Indiana
United States	Yale Cancer Center	New Haven	Connecticut
United States	Tulane University	New Orleans	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of California Irvine Medical Center	Orange	California
United States	PMK Medical Group, Inc.	Oxnard	California
United States	Providence Portland Medical Center	Portland	Oregon
United States	Wilshire Oncology Medical Group, Inc.	Rancho Cucamonga	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Florida Cancer Specialists and Research Institute	Saint Petersburg	Florida
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Cancer Centers of the Carolinas	Seneca	South Carolina
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Texas Oncology-Tyler	Tyler	Texas
United States	American Institute of Research	Whittier	California
United States	Piedmont Hematology Oncology Associates, PLLC	Winston Salem	North Carolina
United States	Piedmont Hematology Oncology Associates, PLLC	Winston-Salem	North Carolina
United States	Metro Health Cancer Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Korea, Republic of,  Romania,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel	Up to three years from last patient study visit	No
Secondary	Progression Free Survival	To determine the progression free survival rate from randomization to progression or death whichever occurs first, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel	Up to three years from last patient study visit	No
Secondary	Overall Response Rate	To determine partial response or complete response occurring at any point post-treatment	Up to three years from last patient study visit	No
Secondary	Time to Progression	To identify the amount of time from randomization to progression, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel	Up to three years from last patient study visit	No