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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IPI 504 plus Docetaxel
Placebo plus Docetaxel
Sponsored by
Infinity Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring LUNG NEOPLASMS, LARGE CELL CARCINOMA, SQUAMOUS CELL CARCINOMA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ironwood Cancer and Research Center
  • Arizona Oncology Associates
  • University of California Irvine Medical Center
  • PMK Medical Group, Inc.
  • Wilshire Oncology Medical Group, Inc.
  • American Institute of Research
  • Yale Cancer Center
  • Florida Cancer Specialists
  • Florida Cancer Specialists and Research Institute
  • Central Indiana Cancer Centers
  • Indiana University
  • Indiana University Health Ball Memorial Hospital
  • Community Hospital
  • Floyd Memorial Cancer Center of Indiana
  • Owsley Brown Frazier Cancer Center-Louisville Downtown
  • Tulane University
  • Massachusetts General Hospital
  • Ann Arbor Hematology Oncology Associates
  • Karmanos Cancer Institute
  • Sparrow Regional Cancer Center
  • Metro Health Cancer Center
  • Southeast Nebraska Cancer Center
  • Broome Oncology, LLC
  • Memorial Sloan-Kettering Cancer Center
  • University of Rochester
  • Blumenthal Cancer Center
  • Piedmont Hematology Oncology Associates, PLLC
  • Piedmont Hematology Oncology Associates, PLLC
  • Oncology Hematology Care, Inc.
  • Signal Point Clinical Research Center, LLC
  • Willamette Valley Cancer Institute and Research Center
  • Providence Portland Medical Center
  • Charleston Hematology Oncology Associates, PA
  • Cancer Centers of the Carolinas
  • Chattanooga Oncology and Hematology Associates, PC
  • Sarah Cannon Cancer Center
  • Texas Oncology-Arlington South
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
  • Texas Oncology-Tyler
  • University of Utah Hospital and Clinics
  • Virginia Cancer Institute
  • Puget Sound Cancer Centers
  • Pándy Kálmán Megyei Kórház
  • Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
  • Mátrai Gyógyintézet
  • Zala Megyei Kórház
  • Országos Korányi TBC és Pulmonológiai Intézet
  • Országos Korányi TBC és Pulmonológiai Intézet
  • National Cancer Center
  • Inha University Hospital
  • Chonnam National University Hwasun Hospital
  • Dong-A University Medical Center
  • Severance Hospital,Yonsei University Health System
  • Asan Medical Center
  • Institutul Oncologic "Prof. Dr. I. Chiricuta"
  • Spitalul de Urgenta "Constantin Opris"
  • Spitalul Municipal Ploiesti
  • Spitalul Clinic Judetean de Urgenta Sibiu
  • City Oncology Hospital # 62
  • State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
  • Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
  • Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ARM 1: IPI 504 + Docetaxel

Placebo + Docetaxel

Arm Description

Drug: IPI-504 plus Docetaxel

Placebo plus Docetaxel

Outcomes

Primary Outcome Measures

Overall Survival
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel

Secondary Outcome Measures

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
Overall Response Rate
To determine partial response or complete response occurring at any point post-treatment
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

Full Information

First Posted
May 26, 2011
Last Updated
May 16, 2014
Sponsor
Infinity Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01362400
Brief Title
A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
LUNG NEOPLASMS, LARGE CELL CARCINOMA, SQUAMOUS CELL CARCINOMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1: IPI 504 + Docetaxel
Arm Type
Active Comparator
Arm Description
Drug: IPI-504 plus Docetaxel
Arm Title
Placebo + Docetaxel
Arm Type
Placebo Comparator
Arm Description
Placebo plus Docetaxel
Intervention Type
Drug
Intervention Name(s)
IPI 504 plus Docetaxel
Other Intervention Name(s)
IPI-504, Docetaxel
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo plus Docetaxel
Other Intervention Name(s)
Docetaxel
Intervention Description
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)
Primary Outcome Measure Information:
Title
Overall Survival
Description
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Time Frame
Up to three years from last patient study visit
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Time Frame
Up to three years from last patient study visit
Title
Overall Response Rate
Description
To determine partial response or complete response occurring at any point post-treatment
Time Frame
Up to three years from last patient study visit
Title
Time to Progression
Description
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
Time Frame
Up to three years from last patient study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tess Schmalbach, MD
Organizational Affiliation
Infinity Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715-4900
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
PMK Medical Group, Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Floyd Memorial Cancer Center of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Owsley Brown Frazier Cancer Center-Louisville Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ann Arbor Hematology Oncology Associates
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48158
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Metro Health Cancer Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Broome Oncology, LLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Piedmont Hematology Oncology Associates, PLLC
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Piedmont Hematology Oncology Associates, PLLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates, PC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Puget Sound Cancer Centers
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Pándy Kálmán Megyei Kórház
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
City
Sopron
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Mátrai Gyógyintézet
City
Mátraháza
State/Province
Heves
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Zala Megyei Kórház
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
411-769
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Jung Gu
State/Province
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Severance Hospital,Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-876
Country
Korea, Republic of
Facility Name
Institutul Oncologic "Prof. Dr. I. Chiricuta"
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul de Urgenta "Constantin Opris"
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430031
Country
Romania
Facility Name
Spitalul Municipal Ploiesti
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100337
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
500245
Country
Romania
Facility Name
City Oncology Hospital # 62
City
Moscow Region
State/Province
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
City
Chelaybinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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