Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cabozantinib + Pemetrexed Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day. |
Drug: Cabozantinib
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
Drug: Pemetrexed
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
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Outcome Measures
Primary Outcome Measures
- Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed [4 weeks or 28 days assessment.]
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
Secondary Outcome Measures
- Assess objective response rate (RR) [To be measured through study completion; an average of 1 year.]
RR measured by Tumor response evaluation with RECIST
- Progression-free survival (PFS) [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). [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
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18 years or older.
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At least one prior chemotherapy before entering in this trial.
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Not pregnant or breastfeeding.
Exclusion Criteria:
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Prior treatment with cabozantinib.
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Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
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History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Augusta University Georgia Cancer Center | Augusta | Georgia | United States | 30912 |
Sponsors and Collaborators
- Augusta University
Investigators
- Principal Investigator: Nagla A Karim, MD, PhD, Augusta University Georgia Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IST-65