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

Published: 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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