Back to resultsBosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bosutinib
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
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.
Sites / Locations
- Augusta University Georgia Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bosutinib and Pemetrexed
Arm Description
Bosutinib and pemetrexed
Outcomes
Primary Outcome Measures
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Maximum tolerated dose of the combination of bosutinib and pemetrexed
Secondary Outcome Measures
Adverse events of the combination of bosutinib and pemetrexed
Anti-tumor response rate
Progression-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03023319
Brief Title
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Official Title
Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nagla Abdel Karim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Mesothelioma, Bladder Cancer, Ovarian Cancer, Peritoneal Cancer, Thymoma, Thymus Cancer, Uterine Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bosutinib and Pemetrexed
Arm Type
Experimental
Arm Description
Bosutinib and pemetrexed
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
100mg daily for 4 cycles (21 days per cycle)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500 mg/m2 every 21 days for 4 cycles
Primary Outcome Measure Information:
Title
Dose-limiting toxicity of the combination of bosutinib and pemetrexed
Description
CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
Time Frame
21 days
Title
Maximum tolerated dose of the combination of bosutinib and pemetrexed
Time Frame
completion of dose escalation
Secondary Outcome Measure Information:
Title
Adverse events of the combination of bosutinib and pemetrexed
Time Frame
16 weeks
Title
Anti-tumor response rate
Time Frame
6 and 12 weeks
Title
Progression-free survival
Time Frame
6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagla Karim, MD
Organizational Affiliation
Augusta University Georgia Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
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