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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603356
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : September 27, 2011
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: OSI-930 and erlotinib Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
Study Start Date : November 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 1
Dose Escalation
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Primary Outcome Measures :
  1. Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603356

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United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals
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Responsible Party: Astellas Pharma Inc Identifier: NCT00603356    
Other Study ID Numbers: OSI-930-103
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011
Keywords provided by Astellas Pharma Inc:
Ovarian Cancer
Colorectal Cancer
Additional relevant MeSH terms:
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Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action