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Completed

NCT Number: NCT02076230

A Phase 1 TH-302 Mass Balance Trial

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.

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Key information

Conditions

Solid Tumor

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Please contact the Merck KGaA Communication Center located in

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C] TH-302 (Label 1)

Drug

[14C]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.

[14C] TH-302 (Label 2)

Drug

[14C]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.

Unlabeled TH-302

Drug

Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.

Primary outcomes

  1. Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM

    Time frame: Days 1 and 8 of Cycle 1

  2. Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM

    Time frame: Day 1 of Cycle 1

Secondary outcomes

  1. Number of subjects with Treatment-emergent adverse events (TEAEs)

    Time frame: Baseline up to Day 30 after the last dose of study treatment

  2. Blood to plasma ratio of total 14C-radioactivity

    Time frame: Days 1 and 8 of Cycle 1

  3. Total and free plasma concentrations of TH-302 in plasma

    Time frame: Day 1 of Cycle 1

  4. Number of subjects with tumor response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Time frame: Up to 1 year

    Tumor response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to RECIST v 1.1.

  5. Unbound fraction (fu) of TH-302 in plasma

    Time frame: Day 1 of Cycle 1

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Threshold Pharmaceuticals

Registry information

Official study title

A Phase I, Open-Label, Two-Center Trial to Investigate the Mass Balance and Metabolite Profile of TH-302 in Cancer Patients With Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Mar 3, 2014
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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