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COMPLETEDPHASE1

A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer

A Japanese Single Center, Open-label, Phase I Trial of TH-302 Given Intravenously to Subjects With Solid Tumors as Monotherapy or to Subjects With Advanced Pancreatic Cancer in Combination With Gemcitabine

NCT01833546•Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic cancer.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 20 years of age
•Signed written informed consent form
•Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available
•Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy or systemic therapy
•Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy of at least 3 months
•Acceptable liver function, renal function, hematologic status and coagulation status as defined in the protocol
•No clinically significant abnormalities in urinalysis
•Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria

•Prior anti-cancer treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
•Prior treatment with gemcitabine for their advanced or metastatic pancreatic cancer, except for radiosensitizing doses of gemcitabine
•Prior radiotherapy to more than 30 percent of the bone marrow within 6 months prior to the trial entry
•Cardiac disease with New York Heart Association (NYHA) Class 3 or 4, within 6 months prior to the trial entry
•Clinically significant (that is, active) cardiovascular disease
•Seizure disorders requiring anticonvulsant therapy
•Known brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for at least 3 months at the trial entry)
•Previously treated malignancies other than the current disease for at least 5 years at the trial entry
•Severe chronic obstructive or other pulmonary disease major surgery, within 4 weeks prior to the trial entry, without complete recovery
•Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
+9 more criteria

Locations (2)

Research Site

Kashiwa, Japan

Research Site

Tokyo, Japan

Key Dates

Start Date

April 18, 2013

Primary Completion Date

August 31, 2015

Completion Date

January 25, 2016

Last Updated

October 15, 2018

Enrollment

ACTUAL participants

Conditions

Solid TumorPancreatic Cancer

Interventions

Evofosfamide

DRUG

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

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