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

December 26, 2007
January 29, 2008
September 27, 2011
November 2007
April 2010   (Final data collection date for primary outcome measure)
Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT00603356 on Archive Site
Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
Phase I Study of OSI-930 and Erlotinib in Cancer Tumors
A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

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.

Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
Experimental: 1
Dose Escalation
Intervention: Drug: OSI-930 and erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
OSI Pharmaceuticals
Not Provided
Astellas Pharma Inc
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP