Study on TAK-788 for Adults with Non-Small Cell Lung Cancer

Sponsor: Takeda

Sponsor score: 60

ClinicalTrials ID:NCT02716116

This clinical trial is testing a new medication called TAK-788, also known as mobocertinib, to see if it is safe and effective for treating adults with non-small cell lung cancer (NSCLC). The study will explore how the body processes TAK-788 and determine the best dose for treatment.

Patient Parameters

Parameter	Options

Program Overview

The study aims to evaluate the safety and effectiveness of TAK-788, a medication for non-small cell lung cancer (NSCLC). Participants will take TAK-788 capsules, sometimes with chemotherapy, to see how well it works and if there are any side effects. The study will also look at how TAK-788 is processed in the body and find the best dose for treatment. Non-Asian, non-White participants will also be included to assess the safety and tolerability of TAK-788.

Description

This study is divided into three parts:

Dose Escalation (Part 1): This phase will determine the safety of TAK-788, including the highest dose that can be given safely, any side effects, and how the drug is processed in the body.
Expansion Phase (Part 2): This phase will evaluate how well TAK-788 works against tumors in different groups of patients with specific genetic mutations in their cancer. These groups include:
- Patients with NSCLC and specific EGFR or HER2 mutations.
- Patients with NSCLC who have not responded to previous treatments.
- Patients with other solid tumors that have EGFR or HER2 mutations.
Extension Phase (Part 3): This phase will focus on patients with advanced NSCLC who have specific EGFR mutations and have been treated before.

The study will involve 324 participants and aims to find out if TAK-788 can help shrink tumors and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

Must have cancer that has not responded to standard treatments.
For specific groups, must have certain genetic mutations in their cancer, confirmed by a test.
Must have been treated with at least one previous cancer therapy for advanced disease.
Must not have active brain metastases unless they have been treated and are stable.
Must be able to provide a tumor sample for testing.
Must be willing to use effective birth control during the study.

Exclusion Criteria

Have previously taken TAK-788.
Have taken certain cancer treatments recently before starting TAK-788.
Have another type of cancer, except for certain skin or cervical cancers.
Have had recent radiation therapy or major surgery.
Have active brain metastases that are not stable.
Have significant heart problems or uncontrolled high blood pressure.
Have active infections or a history of certain viral infections.
Are pregnant or breastfeeding.
Have any condition that might affect the safety or effectiveness of the treatment.

Locations

FACILITY	ZIP	CITY	STATE
Brookwood Medical Center	35209	Birmingham	Alabama
Banner MD Anderson Cancer Center	85234	Gilbert	Arizona
The Oncology Institute of Hope and Innovation - West Tucson	85745	Tucson	Arizona
City of Hope Comprehensive Cancer Center - Duarte	91010	Duarte	California
Compassionate Cancer Care - Fountain Valley	92708	Fountain Valley	California
University of California San Diego Moores Cancer Center	92093	La Jolla	California
Pacific Shores Medical Group-Long Beach Elm	90813	Long Beach	California
Cancer and Blood Specialty Clinic	90720	Los Alamitos	California
University of California Irvine Health Chao Family Comprehensive Cancer Center	92868	Orange	California
Stanford Cancer Center - Palo Alto	94305	Palo Alto	California

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