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

Phase 1

Terminated

• Conditions: Non Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Urothelial Carcinoma; Malignant Mesothelioma
• Interventions: Drug: Cabozantinib; Drug: Pemetrexed

• Registration Number: NCT04173338
• Lead Sponsor: Augusta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Study Start: 2020-01-23
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib + Pemetrexed	Cabozantinib	Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
Cabozantinib + Pemetrexed	Pemetrexed	Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Augusta University Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States