Brief Title
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
Official Title
Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
Brief Summary
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Secondary Outcome
Assess objective response rate (RR)
Condition
Non Small Cell Lung Cancer
Intervention
Cabozantinib
Study Arms / Comparison Groups
Cabozantinib + Pemetrexed
Description: Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
January 23, 2020
Completion Date
March 28, 2022
Primary Completion Date
March 28, 2022
Eligibility Criteria
Inclusion Criteria: - Locally advanced NSCLC, urothelial cancer or malignant mesothelioma. - 18 years or older. - At least one prior chemotherapy before entering in this trial. - Not pregnant or breastfeeding. Exclusion Criteria: - Prior treatment with cabozantinib. - Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study). - History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nagla A Karim, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04173338
Organization ID
IST-65
Responsible Party
Principal Investigator
Study Sponsor
Augusta University
Study Sponsor
Nagla A Karim, MD, PhD, Principal Investigator, Augusta University Georgia Cancer Center
Verification Date
June 2022