Clinical trial NCT00603356 (phase 1, status: completed)
Conditions: advanced solid tumors
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: osi-930 and erlotinib
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        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