Clinical Trials /

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

NCT04173338

Description:

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.

Related Conditions:
  • Malignant Mesothelioma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04173338

Trial Eligibility

Document

Title

  • Brief Title: Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
  • 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 IDs

  • ORG STUDY ID: IST-65
  • NCT ID: NCT04173338

Conditions

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

Interventions

DrugSynonymsArms
CabozantinibCabozantinib + Pemetrexed
PemetrexedCabozantinib + Pemetrexed

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cabozantinib + PemetrexedExperimentalPemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
  • Cabozantinib
  • Pemetrexed

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Time Frame:4 weeks or 28 days assessment.
Safety Issue:
Description:Dose-limiting toxicity of grade 3 or higher using CTCAE 5

Secondary Outcome Measures

Measure:Assess objective response rate (RR)
Time Frame:To be measured through study completion; an average of 1 year.
Safety Issue:
Description:RR measured by Tumor response evaluation with RECIST
Measure:Progression-free survival (PFS)
Time Frame:To be measured through study completion; an average of 1 year.
Safety Issue:
Description:PFS measured from the time of study treatment to the date of progression.
Measure:Overall survival (OS).
Time Frame:OS measured through study completion, and an average of 1 year
Safety Issue:
Description:Measured from the time of start of treatment to time of death or time of last assessment.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Augusta University

Last Updated

January 25, 2021