A Phase 1 TH-302 Mass Balance Trial

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: [14C] TH-302 (Label 2)

Drug: Unlabeled TH-302

Drug: [14C] TH-302 (Label 1)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02076230

2013-003950-25 (EudraCT Number)

EMR200592-007

Details and patient eligibility

About

This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.

Enrollment

10 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available
Subject has measurable and evaluable disease as RECIST version 1.1
Age greater than or equal to (>=) 18 years and less than or equal to (=<) 70 years
Body mass index (BMI) >= 19 and =< 33 kilogram per square meter (kg/m^2), body weight greater than (>) 50 kilogram (kg)
Eastern cooperative oncology group (ECOG) performance status of 0 to 1
Life expectancy of at least 3 months
At least 4 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is longer, after targeted or biologic therapy
Acceptable renal function, liver function and hematologic status as defined in the protocol
Other protocol-defined inclusion criteria could apply

Exclusion criteria

New York Heart Association (NYHA) Class 3 or 4 congestive heart disease, myocardial infarction within 6 months, unstable arrhythmia, symptomatic ischemic heart disease or symptomatic peripheral arterial vascular disease
Severe chronic obstructive or other pulmonary disease with hypoxemia as defined in the protocol
Major surgery, other than diagnostic surgery, =< 28 days prior to Day 1. Subject must have completely recovered from surgery
Primary brain tumors or clinical evidence of active brain metastasis as defined in the protocol
Treatment with strong inhibitors and/or inducers of drug metabolic enzymes or drug transporter as defined in the protocol
Participation in a drug trial within 30 days prior to start of trial medication. Participation in a trial involving administration of 14C-labeled compound(s) within last 6 months prior to start of study drug
Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
Legal incapacity or limited legal capacity
Other protocol-defined exclusion criteria could apply