August 19, 2008 |
April 17, 2009 |
September 2008 |
Determine the maximum tolerated dose (MTD) and recommended phase 2 dose of OSI-906 and erlotinib [ Time Frame: 2.5 ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00739453 on ClinicalTrials.gov Archive Site |
Safety profile, Pharmacokinetic profile, pharmacodynamic activity, Preliminary antitumor activity [ Time Frame: 2.5 ] [ Designated as safety issue: Yes ] |
Same as current |
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A Phase 1 Dose-Escalation Study of OSI-906 and Erlotinib (Tarceva®) |
A Phase I Dose-Escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors |
Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of OSI-906 in combination with erlotinib |
The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is defined as 21 days. Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity >/= grade 2 in any patient on S1 or after > 2 dose levels in S1 have been examined without evidence of DLT. Once the recommended phase 2 dose has been established for S1 and S2, 3 expansion cohorts of up to 10 evaluable patients each will be opened. |
Phase I |
Interventional |
Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Advanced Solid Tumors |
Drug: OSI-906 and/or erlotinib |
- Experimental: Schedule 1 (S1): OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2.
- Experimental: Schedule 2 (S2): OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2
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Recruiting |
75 |
December 2010 |
December 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically or cytologically confirmed advanced solid tumor
- For Expansion Cohort C, a confirmed diagnosis of stage IIIB/IV NSCLC after failure of at least 1 prior chemotherapy regimen is required
- Age >/= 18 years
- ECOG PS 0-2
- Predicted life expectancy >/= 12 weeks
- Patients may have had prior therapy, providing certain conditions are met
- Fasting glucose </= 125 mg/dL (7 mmol/L) at baseline and on Day 1 prior to dosing
- Blood ketones </= ULN
- ANC >/= 1.5 x 10^9/L, Platelets >/= 100 x 10^9/L; bilirubin </= 1.5 x ULN, AST and/or ALT </= 2.5 x ULN or </= 5 x ULN if patient has documented liver metastases; serum creatinine </= 1.5 x ULN
- Patients must be nonsmokers (or former smokers who stopped smoking > 3 months previously) and have a negative cotinine test at baseline and on Day
- Patients in the expansion cohorts must have measurable disease per RECIST
- Patients must be accessible for repeat dosing and follow-up, including pharmacokinetic sampling
- Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1
- Patients must provide verbal and written informed consent to participate in the study
Exclusion Criteria:
- Documented history of diabetes mellitus
- History of significant cardiac disease unless the disease is well-controlled
- History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable
- Prior EGFR or IGFR inhibitor therapy
- History of any psychiatric 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 GI abnormalities including inability to take oral medication, requirement for IV alimentation, active peptic ulcer, or prior surgical procedures affecting absorption
- Ocular inflammatory or infectious condition that is not completely resolved prior to registration
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
- Any type of active seizure disorder
- Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
- Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low-dose steroids, within 14 days prior to Day 1 dosing
- Use of proton pump inhibitors within 14 days prior to day 1 dosing
- Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days
- Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study
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Both |
18 Years and older |
No |
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United States, United Kingdom |
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NCT00739453 |
Karsten Witt, MD, VP Clinical Development, OSI Pharmaceuticals |
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OSI Pharmaceuticals |
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Study Director: |
Andrew Stephens, M.D., PhD |
OSI Pharmaceuticals |
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OSI Pharmaceuticals |
April 2009 |