Clinical trial NCT01362400: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: LUNG NEOPLASMS
LARGE CELL CARCINOMA
SQUAMOUS CELL CARCINOMA
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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