Advanced Solid Tumors
Conditions
Keywords
GIST, Ovarian Cancer, Mesothelioma, Renal, Colorectal Cancer, Sarcoma, NSCLC, Cancer
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.
Interventions
DRUGOSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
Sponsors
OSI Pharmaceuticals
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety, evaluate pharmacodynamic relationships | 18 months |
Countries
United Kingdom, United States
Outcome results
None listed