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, Trial ID OSI-906-207

Study summary

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.

Additional Study Details

Phase

Product

N/A

Product

OSI-906

Erlotinib

Placebo

Type

Interventional

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

Show Additional Study Details

Study documents

Scientific Results Summary

Available Language(s): English

Download Document(s)

Plain Language Summary

Available Language(s): English

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Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling out your information to the right and we’ll respond to you.

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Locations

Withdrawn

Providence St. Joseph Medical Center

Burbank, California, United States, 91505

Withdrawn

Chao Family Comprehensive Cancer Center - University California

Irvine, California, United States, 92868

Completed

Cleveland Clinic Florida

Weston, FL, United States, 33331

Completed

Asan Medical Center

Songpa-gu, Seoul, Republic of Korea, 138736

Completed

Chonnam National University Hwasun Hospital

Ilsimri, Hwasun-gun, Republic of Korea, 519809

Completed

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Completed

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Completed

University of Tennessee Cancer Institute

Memphis, Tennessee, United States, 31804

Completed

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Completed

Johns Hopkins Singapore International Medical Centre

Singapore, Singapore, 308433

Withdrawn

Hematology Oncology Associates of the Treasure Coast

Port St. Lucie, Florida, United States, 34952

Completed

National Cancer Institute

Phayathai, Bangkok, Thailand, 10400

Completed

Rush University Medical Center

Chicago, IL, United States, 60612

Completed

University of California, San Diego/Moores Cancer Center

La Jolla, CA, United States, 92093

Completed

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

Withdrawn

Mount Elizabeth Medical Centre

Singapore, Singapore, 228510

Completed

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Completed

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Completed

Korea University Anam Hospital

Seoul, Republic of Korea, 136705

Completed

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Completed

Songklanagarind Hospital, Prince of Songkla University

Songkla, Thailand, 90110

Withdrawn

Pacific Cancer Medical Center

Anaheim, California, United States, 92801

Completed

Seoul National University Bundang Hospital

Seongnam-si, Republic of Korea, 463-707

Withdrawn

Bumrungrad Hospital Public Company, Ltd. Clinical Research Center

Bangkok, Thailand, 10110

Completed

Oncocare Cancer Center

Singapore, Singapore, 258499

Withdrawn

Inha University Hospital

Inchon, Republic of Korea, 400711

Completed

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Completed

Samsung Medical Center

Seoul, Republic of Korea, 135710

Completed

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Withdrawn

Queen Mary Hospital

Pokfulam, Hong Kong, Hong Kong

Completed

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong, 852

Withdrawn

Monrefiore Medical Center

Bronx, NY, United States, 10467

Completed

Khon Kaen University

Khon Kaen, Thailand, 40002

Withdrawn

University Hospitals of Clevelnd

Cleveland, Ohio, United States, 44106

Completed

Seattle Cancer Care Alliance University of Washington

Seattle, Washington, United States, 98109

Completed

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Withdrawn

Gachon University Gil Medical Center

Incheon, Republic of Korea, 405760

Completed

Maharaj Nakorn Chiangmai

Chiang Mai, Thailand, 50002

Completed

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Completed

Northwestern Memorial Hospital

Chicago, IL, United States, 60611

Trial info

Follow Trial

Age

18+ years

Condition

Non Small Cell Lung Cancer

Sex

Female & Male

Trial Dates

Apr 2011 - Mar 2013

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Additional Study Details

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:

a. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or

b. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).

Or, if of childbearing potential:

a. must have a negative urine pregnancy test at Screening, and

b. 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

Frequently Asked Questions

Are clinical trials only for people with advanced cancer?

While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

Will I have to stop my current treatment to participate in a clinical trial?

Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

Should I be worried about getting a placebo?

In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

Do I need a referral from my doctor to take part in a study?

Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

Explore More

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

Study summary

Additional Study Details

Study documents

Get more information

Locations

Frequently Asked Questions

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