Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Sponsor study identifier
interventional
6
1 country
1
Study Start
December 10, 2019
Actual (reported)Primary Completion
May 10, 2022
Actual (reported)Study Completion
May 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2017
Actual (reported)January 18, 2017
Actual (reported)December 10, 2019
Actual (reported)May 10, 2022
Actual (reported)May 10, 2022
Actual (reported)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
Maximum tolerated dose of the combination of bosutinib and pemetrexed
completion of dose escalation
Adverse events of the combination of bosutinib and pemetrexed
16 weeks
Bosutinib and pemetrexed
100mg daily for 4 cycles (21 days per cycle)
500 mg/m2 every 21 days for 4 cycles
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912, United States
Nagla Karim, MD
Augusta University Georgia Cancer Center
6 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2017
First Posted
January 18, 2017
Study Start
December 10, 2019
Actual (reported)Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects
Anti-tumor response rate
6 and 12 weeks
Progression-free survival
6 and 12 weeks
Contact the study team to confirm eligibility.
Primary Completion
May 10, 2022
Actual (reported)Study Completion
May 10, 2022
Actual (reported)Last Updated
June 14, 2022
Record last verified: 2022-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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