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Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

This study is currently recruiting participants.
Verified by OSI Pharmaceuticals, June 2008

Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603356
  Purpose

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.


Condition Intervention Phase
Advanced Solid Tumors
Drug: OSI-930 and erlotinib
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Erlotinib    Erlotinib hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   60
Study Start Date:   November 2007
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Dose Escalation
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Detailed Description:

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.

Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

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

Criteria

Inclusion Criteria:

  • Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
  • Age greater than or equal to 18 years
  • ECOG PS 0-2
  • ANC greater than or equal to 1.5 x 10^9/L
  • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
  • Creatinine less than or equal to 1.5 ULN
  • Predicted life expectancy greater than or equal to 12 weeks
  • Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
  • Prior tyrosine kinase inhibitor therapy is permitted
  • Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
  • Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
  • Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
  • Prior surgery is permitted, provided that wound healing has occurred prior to registration
  • Patients must use proactive effective contraceptive measures throughout the study
  • Provide written informed consent
  • Accessible for repeat dosing and follow-up
  • Adequate hematopoietic, hepatic, and renal function

Exclusion Criteria:

  • Significant cardiac disease unless well controlled
  • Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
  • Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
  • History of unacceptable toxicity with previous ECFR inhibitor therapy
  • History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
  • Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
  • Pregnant or breast-feeding females
  • Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
  • History of allergic reaction attributed to a similar compound as study drug
  • GI abnormalities including ability to take oral medications, required for IV alimentation
  • Clinically significant ophthalmologic abnormalities
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603356

Contacts
Contact: OSIP Medical Informaiton     800.572.1932, x7821     medical-information@osip.com    
Contact: Tarceva Medical Information Direct     303-546-7821     medical-information@osip.com    

Locations
United States, Florida
H Lee Moffitt Cancer Center and Research Institute     Active, not recruiting
      Tampa, Florida, United States, 33612
United Kingdom
The Beatson West of Scotland Cancer Centre     Recruiting
      Glasgow, United Kingdom, G12 0YN
      Contact: OSIP Medical Informaiton     800.572.1932 ext 7821     medical-information@osip.com    

Sponsors and Collaborators
OSI Pharmaceuticals
  More Information


Responsible Party:   OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development )
Study ID Numbers:   OSI-930-103
First Received:   December 26, 2007
Last Updated:   June 13, 2008
ClinicalTrials.gov Identifier:   NCT00603356
Health Authority:   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by OSI Pharmaceuticals:
GIST  
Ovarian Cancer  
Mesothelioma  
Renal  
Colorectal Cancer
Sarcoma
NSCLC
Cancer

Study placed in the following topic categories:
Erlotinib
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Malignant mesenchymal tumor
Sarcoma
Mesothelioma
Soft tissue sarcomas
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on November 20, 2008




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