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

• Sponsor: Nagla Abdel Karim (Other)
• Overall Status: Completed
• CT.gov ID: NCT03023319
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 29
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Mesothelioma; Bladder Cancer; Ovarian Cancer; Peritoneal Cancer; Thymoma; Thymus Cancer; Uterine Cervical Cancer	Drug: Bosutinib; Drug: Pemetrexed	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
• Actual Study Start Date: Dec 10, 2019
• Actual Primary Completion Date: May 10, 2022
• Actual Study Completion Date: May 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bosutinib and Pemetrexed Bosutinib and pemetrexed	Drug: Bosutinib; 100mg daily for 4 cycles (21 days per cycle); Drug: Pemetrexed; 500 mg/m2 every 21 days for 4 cycles

Outcome Measures

Primary Outcome Measures

1. 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.

2. Maximum tolerated dose of the combination of bosutinib and pemetrexed [completion of dose escalation]

Secondary Outcome Measures

1. Adverse events of the combination of bosutinib and pemetrexed [16 weeks]

2. Anti-tumor response rate [6 and 12 weeks]

3. Progression-free survival [6 and 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augusta University Georgia Cancer Center	Augusta	Georgia	United States	30912

Sponsors and Collaborators

• Nagla Abdel Karim

Investigators

• Principal Investigator: Nagla Karim, MD, Augusta University Georgia Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nagla Abdel Karim, Associate Professor of Medicine, Augusta University
• ClinicalTrials.gov Identifier: NCT03023319
• Other Study ID Numbers: EXP-16-01
• First Posted: Jan 18, 2017
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Mesothelioma; Carcinoma, Non-Small-Cell Lung; Thymoma; Thymus Neoplasms; Pemetrexed

Study Results

No Results Posted as of Jun 14, 2022