A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors
Inclusion Criteria:
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or metastatic NSCLC that has previously been treated with erlotinib or
gefitinib
- ECOG Performance Status 0-1
- Adequate organ and bone arrow function as defined by hematological and serum
chemistry limits
- At least 18 years old
- Both men and women must practice adequate contraception
- Informed consent
Exclusion Criteria:
- Restriction of some therapies/medications within specific timeframes prior to
enrollment and during the study including prior therapy with PI3K, cytotoxic
chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase
inhibitors, non-cytotoxic hormonal agents
- Erlotinib intolerant
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus and an HgbA1c > 7%
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months
of entering the study.
- HIV positive
- Diagnosis of another malignancy may exclude subject from study