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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 EGFR 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 inability 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 Completed
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
Study First Received: December 26, 2007
Last Updated: November 24, 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 January 14, 2009