Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

January 19, 2017

Primary Outcome Measures

Dose-limiting toxicity of the combination of bosutinib and pemetrexed [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
CTCAE Grade 3 or 4 non‐hematologic toxicities other than alopecia, nausea and vomiting.
Maximum tolerated dose of the combination of bosutinib and pemetrexed [ Time Frame: completion of dose escalation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures

Adverse events of the combination of bosutinib and pemetrexed [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Anti-tumor response rate [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Eligibility

Inclusion Criteria: Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer.; Measurable disease; Life expectancy of greater than 3 months.; Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria: Untreated or symptomatic brain metastases.

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