Phase I Study of OSI-930 and Erlotinib in Cancer Tumors
- Registration Number
- NCT00603356
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 OSI-930 and erlotinib Dose Escalation
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles 18 months
- Secondary Outcome Measures
Name Time Method Safety, evaluate pharmacodynamic relationships 18 months
Trial Locations
- Locations (2)
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States