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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Peritoneal Cancer; Thymus Cancer; Mesothelioma; Thymoma; Uterine Cervical Cancer; Bladder Cancer; Ovarian Cancer
• Interventions: Drug: Bosutinib; Drug: Pemetrexed

• Registration Number: NCT03023319
• Lead Sponsor: Nagla Abdel Karim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Study Start: 2019-12-10
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bosutinib and Pemetrexed	Pemetrexed	Bosutinib and pemetrexed
Bosutinib and Pemetrexed	Bosutinib	Bosutinib and pemetrexed

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity of the combination of bosutinib and pemetrexed	21 days	CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Maximum tolerated dose of the combination of bosutinib and pemetrexed	completion of dose escalation

Secondary Outcome Measures

Name	Time	Method
Adverse events of the combination of bosutinib and pemetrexed	16 weeks
Anti-tumor response rate	6 and 12 weeks
Progression-free survival	6 and 12 weeks

Trial Locations

Locations (1)

Augusta University Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States