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

Nagla Abdel Karim

Status and phase: Completed; Phase 1

Conditions: Thymoma; Thymus Cancer; Uterine Cervical Cancer; Bladder Cancer; Carcinoma, Non-Small-Cell Lung; Peritoneal Cancer; Mesothelioma; Ovarian Cancer

Treatments: Drug: Bosutinib; Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT03023319

EXP-16-01

Details and patient eligibility

About

This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Bosutinib and Pemetrexed

Experimental group

Description:

Bosutinib and pemetrexed

Treatment:

Drug: Pemetrexed

Drug: Bosutinib