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

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

INTRODUCTION

  • Org Study ID: IST-65
  • Secondary ID: N/A
  • NTC ID: NCT04173338
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    January 23, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed

Primary Outcome 1 - Timeframe: 4 weeks or 28 days assessment.

CONDITION

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

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nagla A Karim, MD, PhD

Role: Principal Investigator

Affiliation: Augusta University Georgia Cancer Center

Overall Contact

Name: Nagla A Karim, MD, PhD

Phone: 706-721-1206, 706-721-0660

Email: kejenkins@augusta.edu, asstevenson@augusta.edu

LOCATION

Facility Status Contact
Facility: Augusta University Georgia Cancer Center
Augusta, Georgia 30912
United States
Status: Recruiting Contact: Principal Investigator
Nagla A Karim, MD, PhD