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A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)
This study is currently recruiting participants.
Verified by OSI Pharmaceuticals, July 2009
First Received: August 19, 2008   Last Updated: August 3, 2009   History of Changes
Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739453
  Purpose

Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of OSI-906 in combination with erlotinib


Condition Intervention Phase
Advanced Solid Tumors
Drug: OSI-906 and/or erlotinib
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title: A Phase I Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety profile, Pharmacokinetic profile, pharmacodynamic activity, Preliminary antitumor activity [ Time Frame: 2.5 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Schedule 1 (S1): OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2.
Drug: OSI-906 and/or erlotinib
Oral OSI-906 and/or erlotinib administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
2: Experimental
Schedule 2 (S2): OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2
Drug: OSI-906 and/or erlotinib
Oral OSI-906 and/or erlotinib administered on a continuous schedule at increasing doses until disease progression or unacceptable toxicity

Detailed Description:

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.

  Eligibility

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

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 1
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739453

Contacts
Contact: OSIP Medical Information 800.572.1932, x7821 medical-information@osip.com

Locations
United States, Colorado
University of Colorado Health Science Center Recruiting
Aurora, Colorado, United States, 80045
Contact: OSIP Medical Information     800-572-1932 ext 7821     medical-information@osip.com    
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: OSIP Medical Information     800-572-1932 ext 7821     medical-information@osip.com    
United States, Michigan
Hudson-Webber Cancer Research Center, Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: OSIP Medical Information     800-572-1932 ext 7821     medical-information@osip.com    
United Kingdom
University of Oxford Department of Medical Oncology Recruiting
Oxford, United Kingdom, OX3 7LJ
Contact: OSIP Medical Information     800-572-1932 ext 7821     medical-information@osip.com    
Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: Andrew Stephens, M.D., PhD OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development )
Study ID Numbers: OSI-906-103
Study First Received: August 19, 2008
Last Updated: August 3, 2009
ClinicalTrials.gov Identifier: NCT00739453     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:
Advanced cancer
Non-small cell lung cancer
Pancreatic cancer
Colorectal cancer
Prostate cancer

Study placed in the following topic categories:
Erlotinib
Lung Neoplasms
Pancreatic Neoplasms
Non-small Cell Lung Cancer
Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Prostatic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Erlotinib
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009