Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04173338|
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Non-squamous Non-small-cell Lung Cancer Urothelial Carcinoma Malignant Mesothelioma||Drug: Cabozantinib Drug: Pemetrexed||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 23, 2020|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Cabozantinib + Pemetrexed
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
- Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed [ Time Frame: 4 weeks or 28 days assessment. ]Dose-limiting toxicity of grade 3 or higher using CTCAE 5
- Assess objective response rate (RR) [ Time Frame: To be measured through study completion; an average of 1 year. ]RR measured by Tumor response evaluation with RECIST
- Progression-free survival (PFS) [ Time Frame: To be measured through study completion; an average of 1 year. ]PFS measured from the time of study treatment to the date of progression.
- Overall survival (OS). [ Time Frame: OS measured through study completion, and an average of 1 year ]Measured from the time of start of treatment to time of death or time of last assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173338
|Contact: Kelly Jenkins, MSN, RNemail@example.com|
|Contact: Ashlyn Stevenson, BSN, RNfirstname.lastname@example.org|
|United States, Georgia|
|Augusta University Georgia Cancer Center||Recruiting|
|Augusta, Georgia, United States, 30912|
|Principal Investigator: Nagla A Karim, MD, PhD|
|Principal Investigator:||Nagla A Karim, MD, PhD||Augusta University Georgia Cancer Center|