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NCT04173338 Clinical Trial

Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04173338
Other study ID # IST-65
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date January 23, 2020
Est. completion date March 28, 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 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.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date March 28, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cabozantinib
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
• Pemetrexed
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.

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

Sponsors (1)
Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed Dose-limiting toxicity of grade 3 or higher using CTCAE 5 4 weeks or 28 days assessment.
Secondary Assess objective response rate (RR) RR measured by Tumor response evaluation with RECIST To be measured through study completion; an average of 1 year.
Secondary Progression-free survival (PFS) PFS measured from the time of study treatment to the date of progression. To be measured through study completion; an average of 1 year.
Secondary Overall survival (OS). Measured from the time of start of treatment to time of death or time of last assessment. OS measured through study completion, and an average of 1 year
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