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

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Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. 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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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed

Secondary Outcome

 Assess objective response rate (RR)

Condition

Non Small Cell Lung Cancer

Intervention

Cabozantinib

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

9

Start Date

January 23, 2020

Completion Date

March 28, 2022

Primary Completion Date

March 28, 2022

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nagla A Karim, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04173338

Organization ID

IST-65

Responsible Party

Principal Investigator

Study Sponsor

Augusta University

Study Sponsor

Nagla A Karim, MD, PhD, Principal Investigator, Augusta University Georgia Cancer Center

Verification Date

June 2022