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

NCT04173338 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IST-65
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess objective response rate (RR)

  To be measured through study completion; an average of 1 year.

• Progression-free survival (PFS)

  To be measured through study completion; an average of 1 year.

• Overall survival (OS).

  OS measured through study completion, and an average of 1 year

Study Arms (1)

Cabozantinib + Pemetrexed

EXPERIMENTAL

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

Drug: Cabozantinib; Drug: Pemetrexed

Interventions

Cabozantinib DRUG

start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.

Cabozantinib + Pemetrexed

Pemetrexed DRUG

Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.

Cabozantinib + Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
• years or older.
• At least one prior chemotherapy before entering in this trial.
• Not pregnant or breastfeeding.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Mesothelioma, Malignant

Interventions

cabozantinib; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Nagla A Karim, MD, PhD

  Augusta University Georgia Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: January 23, 2020
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)