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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603356
• Other study ID #: OSI-930-103
• Status: Completed
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: September 26, 2011
• Start date: November 2007
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles		18 months	No
Secondary	Safety, evaluate pharmacodynamic relationships		18 months	Yes