Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations treated with TAK-788 when administered with or without intensive loperamide prophylaxis.


Clinical Trial Description

The drug being tested in this study is called TAK-788. TAK-788 administered with or without antidiarrheal prophylaxis is being tested to evaluate the impact of management strategies on gastrointestinal-related adverse events in participants with non-small cell lung cancer harboring EGFR Exon 20 insertion mutations receiving TAK-788. The study will enroll approximately 90 patients. Participants will be randomly assigned in 1:1 ratio (by chance, like flipping a coin) to one of the two treatment groups- - Cohort 1 - Cohort 2 All participants will be asked to take TAK-788 capsules with or without a low-fat meal in Cohort 1 and TAK-788 capsule with antidiarrheal prophylaxis and with or without a low-fat meal in Cohort 2. This is a multi-center trial and will be conducted worldwide. The overall time to participate in this study is approximately 2 years. Participants will make multiple visits to the clinic after receiving their last dose of drug for a follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04576208
Study type Interventional
Source Takeda
Contact
Status Withdrawn
Phase Phase 2
Start date November 30, 2020
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT03667820 - Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Phase 2
Completed NCT02025114 - Selumetinib in Combination With Gefitinib in NSCLC Patients Phase 1/Phase 2
Recruiting NCT01994057 - A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
Completed NCT01438307 - Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer Phase 2
Completed NCT01193959 - Pemetrexed in Advanced Non-small Cell Lung Cancer
Recruiting NCT01028729 - A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) Phase 4
Completed NCT00770588 - Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) Phase 4
Active, not recruiting NCT05462717 - Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Phase 1
Completed NCT01951157 - A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients Phase 2
Recruiting NCT01964157 - An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement Phase 2
Active, not recruiting NCT04026412 - A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery Phase 3
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT03260491 - HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer Phase 1
Completed NCT05207423 - A Chart Review Study of Adults With Advanced NSCLC
Terminated NCT02608528 - Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
Completed NCT01463423 - Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR) N/A
Recruiting NCT02927340 - A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Phase 2
Recruiting NCT02521051 - Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer Phase 1/Phase 2