Phase 2 study of Maintenance OSI-906 plus Erlotinib (Tarceva®), or Placebo plus Erlotinib in patients with nonprogression following 4 cycles of platinum-based chemotherapy, Trial ID OSI-906-205

Study summary

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.

Additional Study Details

Phase

Product

N/A

Product

OSI-906

erlotinib

placebo

Type

Interventional

Masking

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

Enrollment number

205

Show Additional Study Details

Study documents

Scientific Results Summary

Available Language(s): English

Download Document(s)

Plain Language Summary

Available Language(s): English

Download Document(s)

Get more information

Would you like more information about clinical trial sites that are recruiting participants for Phase 2 study of Maintenance OSI-906 plus Erlotinib (Tarceva®), or Placebo plus Erlotinib in patients with nonprogression following 4 cycles of platinum-based chemotherapy? Contact us by filling out your information to the right and we’ll respond to you.

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Locations

Completed

Site RO40006

Craiova, Romania, 200535

Completed

Site RU70011

Saint Petersburg, Russian Federation, 197089

Completed

Site DE49005

Minden, Germany, 32429

Completed

Site BR55016

Goiania, Brazil, 74605-030

Completed

Site CA11001

Oshawa, Canada, L1G 2B9

Completed

Site BR55015

Cachoeiro de Itapemirim, Brazil, 29308-014

Withdrawn

Site RU70001

Moscow, Russian Federation, 129128

Completed

Site KR82002

Seoul, Republic of Korea, 137-701

Completed

Site PL48005

Szczecin, Poland, 70-891

Withdrawn

Site US10006

Buffalo, NY, United States, 14215

Completed

Site US10004

Greensboro, NC, United States, 27403

Completed

Site BR55005

Barretos, Brazil, 14784-400

Completed

Site GB44005

London, United Kingdom, NW1 2PQ

Withdrawn

Site CA11003

Montreal, Canada, H2W 1S6

Completed

Site CA11004

Ottawa, Canada, K1H 8L6

Completed

Site US10011

Scarborough, ME, United States, 04074

Completed

Site BR55006

Ijui, Brazil, 98700-000

Completed

Site BR55003

Fortaleza, Brazil, 60336-550

Completed

Site DE49015

Kassel, Germany, 34125

Completed

Site KR82003

Seoul, Republic of Korea, 120-752

Completed

Site PL48002

Elblag, Poland, 82-300

Completed

Site GB44001

Manchester, United Kingdom, M20 4BX

Completed

Site DE49009

Homburg/Saar, Germany, 66421

Completed

Site PL48008

Torun, Poland, 87-100

Withdrawn

Site CA11008

Montreal, Canada, H2W 1S6

Completed

Site US10002

Albany, GA, United States, 31701

Completed

Site BR55013

Porto Alegre, Brazil, 90430-090

Completed

Site US10001

Port St. Lucie, FL, United States, 34952

Completed

Site RO40001

Baia Mare, Romania, 490110

Completed

Site RO40005

Alba Iulia, Romania, 510077

Completed

Site BR55011

Florianopolis, Brazil, 88034-000

Completed

Site GB44003

Leeds, United Kingdom, LS9 7TF

Withdrawn

Site RU70004

Saint Petersburg, Russian Federation, 197758

Completed

Site DE49008

Koln, Germany, 51109

Completed

Site BR55001

Itajai, Brazil, 88301-220

Completed

Site DE49013

Mainz, Germany, 55131

Completed

Site DE49002

Hemer, Germany, 58675

Completed

Site DE49001

Heidelberg, Germany, 69126

Completed

Site KR82008

Incheon, Republic of Korea, 400-711

Completed

Site CA11006

Toronto, Canada, M5G 1X5

Completed

Site RO40003

Cluj-Napoca, Romania, 400015

Completed

Site KR82004

Seongnam-si, Republic of Korea, 463-707

Completed

Site RO40004

Hunedoara, Romania, 331057

Completed

Site CA11002

Toronto, Canada, M6R 1B5

Withdrawn

Site PL48004

Warsaw, Poland, 02-781

Completed

Site KR82005

Seoul, Republic of Korea, 135-710

Completed

Site KR82001

Suwon, Republic of Korea

Completed

Site BR55012

Ribeirao Preto, Brazil, 14515-130

Completed

Site BR55004

Brasilia, Brazil, 70840-050

Completed

Site RU70009

Saint Petersburg, Russian Federation, 197089

Completed

Site GB44002

Leicester, United Kingdom, LE1 5WW

Withdrawn

Site PL48003

Warszawa, Poland, 01-138

Withdrawn

Site BR55009

Londrina, Brazil, 86050-190

Completed

Site DE49014

Berlin, Germany, 10117

Completed

Site DE49012

Karlsruhe, Germany, 76137

Completed

Site BR55014

Porto Alegre, Brazil, 90610-000

Completed

Site GB44006

Dundee, United Kingdom, DD1 9SY

Completed

Site KR82007

Busan, Republic of Korea, 602-715

Completed

Site RU70007

Saint Petersburg, Russian Federation, 194291

Completed

Site DE49003

Grosshansdorf, Germany, 22977

Completed

Site RO40007

Brasov, Romania, 500366

Completed

Site GB44007

Bristol, United Kingdom, BS2 8ED

Completed

Site DE49011

Dortmund, Germany, 44145

Completed

Site RO40002

Cluj-Napoca, Romania, 400015

Completed

Site DE49006

Immenhausen, Germany, 34376

Completed

Site US10010

Winston-Salem, NC, United States, 27103

Completed

Site KR82006

Hwasun, Republic of Korea, 519-809

Completed

Site GB44004

Southampton, United Kingdom, SO16 6YD

Completed

Site RU70010

Kazan, Russian Federation, 420029

Completed

Site BR55002

Rio de Janeiro, Brazil, 20231-050

Completed

Site US10007

Jacksonville, FL, United States, 32207

Completed

Site RU70002

Chelaybinsk, Russian Federation, 454087

Completed

Site PL48006

Wroclaw, Poland, 53-439

Completed

Site BR55008

Piracicaba, Brazil, 13419-155

Withdrawn

Site US10005

Morristown, NJ, United States, 07962-1089

Completed

Site BR55007

Sao Paulo, Brazil, 01323-920

Completed

Site US10008

Chicago, IL, United States, 60612

Withdrawn

Site CA11007

Montreal, Canada, H2W 1S6

Withdrawn

Site RU70008

Nizhniy Novgorod, Russian Federation, 603081

Completed

Site DE49010

Lubeck, Germany, 23538

Trial info

Follow Trial

Age

18+ years

Condition

Non Small Cell Lung Cancer

Sex

Female & Male

Trial Dates

Mar 2011 - Jul 2013

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Additional Study Details

Inclusion Criteria

Histologically confirmed locally advanced or metastatic stage IIIB or IV NSCLC
Have experienced Complete Response (CR), Partial Response (PR) or Stable Disease (SD) following completion of 4 cycles of first-line platinum-based chemotherapy and are not progressing at time of entry into study (prior completed first-line combination bevacizumab therapy is permitted; however, current use of maintenance bevacizumab is not permitted. A maximum interval of 28 days between the last day of the treatment cycle and randomization
Patient has recovered from prior chemotherapy-related toxicity to ≤ grade 2
EGFR mutation status must be confirmed for participation in the study. EGFR analysis 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 APGD 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 centrally for biomarker 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 (for those patients with PR or SD after first-line platinum-based chemotherapy) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 0 - 1
Previous adjuvant or neo-adjuvant treatment is permitted
Must be able to take oral medication
Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization
Adequate hematopoietic, hepatic, and renal function defined as follows:
- Neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN)
- AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if patient has documented liver metastases
- Serum creatinine ≤ 1.5 x ULN
Potassium, magnesium and calcium within normal limits (supplementation and retesting is permitted)

Female patient must be either:

Of non child bearing potential:
- post-menopausal (defined as at least 1 year without any menses) prior to

Screening, or

documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
Or, if of childbearing potential:
- must have a negative urine pregnancy test at Screening, and
- must use two forms of birth control (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
Female patient must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration
Female patient must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration
Male patient 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
Male patient must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration
Prior radiation therapy is permitted provided patients have recovered from 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 performed 21 days prior to randomization and adequate wound healing has occurred prior to randomization
Patients must provide written (signed) informed consent to participate in the study and for use of tumor tissues

Exclusion Criteria

Prior exposure to agents directed at the Human Epidermal Receptor (HER) axis (eg, erlotinib, gefitinib, cetuximab, and trastuzumab)
Malignancies other than NSCLC within 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)
Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
Prior insulin-like growth factor receptor (IGF-1R)
Prior investigational agent within 21 days prior to randomization
Concurrent use of maintenance bevacizumab
History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease, ulcerative colitis, etc)
History (within last 180 days) 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 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 based on independent central reviewer analysis of screening visit ECGs
Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to randomization
Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
Use of potent CYP3A4 inhibitor such as ketoconazole, clarithromycin, atazanavir, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole
Use of proton pump inhibitors such as omeprazole. Use of H2-receptor antagonists such as ranitidine are not excluded
History of cerebrovascular accident (CVA) within 180 days prior to randomization or that resulted in ongoing neurologic instability
Active infection, serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization), or serious chronic illness that would impair the ability of the patient to receive study drug
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
Symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment (e.g., anti-epileptic medication) within 21 days prior to randomization
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
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

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

Phase 2 study of Maintenance OSI-906 plus Erlotinib (Tarceva®), or Placebo plus Erlotinib in patients with nonprogression following 4 cycles of platinum-based chemotherapy

Study summary

Additional Study Details

Study documents

Get more information

Locations

Frequently Asked Questions

Explore More

What are clinical trials?

Why are Clinical Trials Important?

Why Participate in a Clinical Trial?