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
• Status: Terminated
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant
• Non Small Cell Lung Cancer
• Non-squamous Non-small-cell Lung Cancer
• Urothelial Carcinoma

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