Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT04173338|
Recruitment Status : Terminated (Closed by IRB on 3/28/22)
First Posted : November 21, 2019
Last Update Posted : June 14, 2022
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|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)|
|Actual Enrollment :||9 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|
|Actual Primary Completion Date :||March 28, 2022|
|Actual Study Completion Date :||March 28, 2022|
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Georgia|
|Augusta University Georgia Cancer Center|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Nagla A Karim, MD, PhD||Augusta University Georgia Cancer Center|
|Responsible Party:||Nagla Abdel Karim, Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program, Augusta University|
|Other Study ID Numbers:||
|First Posted:||November 21, 2019 Key Record Dates|
|Last Update Posted:||June 14, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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