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NCT03023319 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03023319
Other study ID # EXP-16-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 10, 2019
Est. completion date May 10, 2022

Study information
Verified date June 2022
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date May 10, 2022
Est. primary completion date May 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bosutinib
100mg daily for 4 cycles (21 days per cycle)
• Pemetrexed
500 mg/m2 every 21 days for 4 cycles

Locations
Country Name City State
United States Augusta University Georgia Cancer Center Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Nagla Abdel Karim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity of the combination of bosutinib and pemetrexed CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting. 21 days
Primary Maximum tolerated dose of the combination of bosutinib and pemetrexed completion of dose escalation
Secondary Adverse events of the combination of bosutinib and pemetrexed 16 weeks
Secondary Anti-tumor response rate 6 and 12 weeks
Secondary Progression-free survival 6 and 12 weeks
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