Trial record 1 of 2 for:    OSI-906-207
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Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01221077
First received: October 5, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.


Condition Intervention Phase
Non Small Cell Lung Cancer
NSCLC
Drug: OSI-906
Drug: Erlotinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Progression-free survival of OSI-906 in combination with Erlotinib or Erlotinib plus placebo [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Time from randomization to disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator or death due to any cause, whichever occurs first.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    Time from the date of randomization until the documented date of death.

  • Disease Control Rate (DCR) [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease based on RECIST version 1.1 criteria.

  • Best Overall Response Rate [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Duration of Response (CR/PR) [ Time Frame: 33 months ] [ Designated as safety issue: No ]

    Time from the date of the first documented response (CR/PR) to documented progression or death due to underlying cancer.

    Defined for patients whose best overall response was CR or PR.


  • Safety assessed through evaluation of adverse events, laboratory, physical examination, and Electrocardiogram (ECG) data [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Erolitinib plus OSI-906
As of 01 March 2013, OSI-906 is no longer being administered
Drug: OSI-906
As of 01 March 2013, OSI-906 is no longer being administered
Drug: Erlotinib
Erlotinib administered orally
Other Names:
  • Tarceva
  • OSI-774
Placebo Comparator: Arm B: Eroltinib plus Placebo
As of 01 March 2013, the matching placebo is no longer being administered
Drug: Erlotinib
Erlotinib administered orally
Other Names:
  • Tarceva
  • OSI-774
Drug: Placebo
As of 01 March 2013, the matching placebo is no longer being administered

Detailed Description:

Based on the recommendation of the Data Monitoring Committee, OSI-906 and matching placebo are no longer being administered as of 01 March 2013.

This is a multi-center, randomized (1:1), double-blind, placebo-controlled, phase 2 study. Patients will be stratified according to the following 2 parameters: (1) EGFR activating mutation type (exon 19 deletion versus exon 21 single point mutation); and (2) Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Historically confirmed advanced NSCLC stages IIIB or IV
  • Exon 19 deletion or exon 21 activating mutation in EGFR
  • EGFR mutation status must be confirmed for participation in the study. EGFR can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by sponsor prior to randomization. If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or, in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization. Additionally, subjects should provide tissue blocks for biomarker central analysis whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient to provide four 4-micron, and five 10-micron sections
  • Measurable disease according to RECIST (version 1.1)
  • ECOG performance status 0-1
  • Must be able to take oral medication
  • Fasting glucose <= 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic anti hyperglycemic therapy is permitted if the dose has been stable for >= 4 weeks at the time of randomization
  • Adequate hematopoietic, hepatic, and renal function as follows:

    • Neutrophil count >= 1500/uL
    • Platelet count >= 100,000/uL
    • Serum creatinine <= 1.5 x Upper Limit of Normal (ULN)
    • Potassium, magnesium, and calcium within normal limits (supplementation and re-testing is permitted)
    • Total bilirubin <= 1.5 x ULN
    • AST and ALT <= 2.5 x ULN, or <= 5 x ULN if patient has documented liver metastases
  • Female subject must be either:

    • Of non child bearing potential:

      1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
      2. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
    • Or, if of childbearing potential:

      1. must have a negative urine pregnancy test at Screening, and
      2. must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 30 days after final study drug administration. Acceptable forms include:

        1. Established use of oral, injected or implanted hormonal methods of contraception;
        2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);
        3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Female subject must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration.
  • Female subject must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration.
  • Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 30 days after final study drug administration. Acceptable forms include:

    1. Established use of oral, injected or implanted hormonal methods of contraception.
    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration.
  • Patients must provide written informed consent to participate in the study
  • Patients may not have received chemotherapy for advanced NSCLC. Previous adjuvant and/or neoadjuvant treatment for NSCLC is permitted
  • Prior radiation therapy is permitted provided patients have recovered from the acute, toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have elapsed between the end of radiotherapy and randomization
  • Prior surgery is permitted provided that the surgery was done >= 28 days prior to randomization and adequate wound healing has occurred prior to randomization

Exclusion Criteria:

  • Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, and cetuximab)
  • Prior insulin-like growth factor -1 receptor (IGF-1R) inhibitor therapy
  • Malignancies other than NSCLC within the past 3 years (exceptions if curatively treated; basal or squamous cell carcinoma of skin; locally advanced prostate cancer; ductal carcinoma in situ of breast; in situ cervical carcinoma; and superficial bladder cancer)
  • Diabetes mellitus currently requiring insulinotropic or insulin therapy
  • Use of proton pump inhibitors such as omeprazole within 14 days prior to randomization. H2-receptor antagonists such as ranitidine are not excluded
  • Symptomatic brain metastases that are not stable, require steroids, or have required radiation and/or other related treatment (i.e., anti-epileptic medication) within 21 days prior to randomization
  • Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study.
  • History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease or ulcerative colitis)
  • History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but no ordinary physical activity results in fatigue, palpitation, or dyspnea)
  • History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (>= grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded
  • Mean QTcF interval >= 450 msec at screening
  • Use of drugs that have a known risk of causing Torsades de Pointes (TdP) ('Torsades List' on www.azcert.org/medical-pros/drug-lists/bycategory.cfm) are prohibited within 14 days prior to randomization
  • Use of strong/moderate CYP1A2 inhibitors such as ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
  • Use of strong/moderate CYP3A4 inhibitors and inducers
  • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability
  • History of any psychiatric or neurologic condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
  • Pregnant or breast-feeding females
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
  • Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), symptomatic brain metastases, or serious chronic illness that would impair the ability of the patient to receive study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221077

  Hide Study Locations
Locations
United States, California
University of California, San Diego/Moores Cancer Center
La Jolla, California, United States, 92093
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 31804
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle Cancer Care Alliance University of Washington
Seattle, Washington, United States, 98109
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong, 852
Korea, Republic of
Chonnam National University Hwasun Hospital
Ilsimri, Hwasun-gun, Korea, Republic of, 519809
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138736
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 463-707
Korea University Anam Hospital
Seoul, Korea, Republic of, 136705
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
Oncocare Cancer Center
Singapore, Singapore, 258499
Thailand
National Cancer Institute
Phayathai, Bangkok, Thailand, 10400
Maharaj Nakorn Chiangmai
Chiang Mai, Thailand, 50002
Khon Kaen University
Khon Kaen, Thailand, 40002
Songklanagarind Hospital, Prince of Songkla University
Songkla, Thailand, 90110
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01221077     History of Changes
Other Study ID Numbers: OSI-906-207
Study First Received: October 5, 2010
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Singapore: Health Sciences Authority
Hong Kong: Department of Health
Korea: Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
NSCLC
Non-small cell lung cancer
OSI-906
IGF-IR
Tarceva
Erlotinib
Epidermal Growth Factor Receptor
EGFR
Chemonaive
Activating mutations

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitogens
Erlotinib
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014