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Participants will receive single oral dose of M1774 containing a \[14C\]M1774 microtracer solution on day 1 of period 1 under fasted conditions.

M1774 [14C]M1774 microtracer

Participants will receive a single oral dose of M1774 on Day 1 of Period 1, and daily single oral dose of M1774 for 2 weeks in 21 days cycle of Period 2.

M1774

Communication Center

Medical Responsible

This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. Thereafter, participants may enter an optional extension phase (Period 2) where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met.

M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)

Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism and Excretion of M1774 Containing Microtracer [14C] M1774 in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.

Further information on how to request data can be found on our website bit.ly/IPD21.

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Antineoplastic Agents

Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

A single oral dose of 95 mg of GSK2118436 containing approximately 80 µCi of radioactivity

GSK2118436

GSK Clinical Trials

The study is a Phase 1, open-label study designed to characterize the absorption, distribution, metabolism and excretion of GSK2118436 following administration of a single oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive tumors.

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. The study is a Phase 1, open-label study designed to characterize the absorption, distribution, metabolism and excretion of GSK2118436 following administration of a single oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive tumors. A sufficient number of subjects will be enrolled to complete approximately four subjects. Following completion of the study, subjects may continue dosing with GSK2118436 in the rollover study, BRF114144.

An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors

An Open-Label Study to Characterize the Absorption, Distribution, Metabolism and Elimination of a Single Oral 14C Labeled Dose of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

GlaxoSmithKline

TKI258

Novartis Pharmaceuticals

This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.

Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies

An Open-Label, Non-Randomized, Single-Center, Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion (ADME) of TKI258 After a Single Oral Administration of TKI258 500mg and to Assess the Preliminary Safety of TK258 400mg Once Daily in Patients With Advanced Solid Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)	NCT06308263	Solid Tumor	M1774 [14C]M177... M1774	18 Years -	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors	NCT01262963	Cancer	GSK2118436	18 Years -	GlaxoSmithKline
An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors	NCT01262963	Cancer	GSK2118436	18 Years -	GlaxoSmithKline
Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies	NCT00669097	Advanced Solid ...	TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for adme

Every month we try and update this database with for adme cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adme

Every month we try and update this database with for adme cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adme cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.