A Japanese Trial of TH-302 in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02255110|
Recruitment Status : Terminated (Sponsor's decision due to negative result of Phase 3 study TH-CR-406/SARC021)
First Posted : October 2, 2014
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: TH-302 Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-arm, Japanese Multicenter Trial of TH-302 in Combination With Doxorubicin in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
|Experimental: TH-302 and doxorubicin||
TH-302 will be administered at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Days 1 and 8 of every 21-day cycle until the evidence of significant treatment-related toxicity or progressive disease.
Doxorubicin will be administered at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
- Percentage of Subjects with Progression-free Survival (PFS) at 6 months: independent-read assessment [ Time Frame: 6 months ]Percentage of Subjects with Progression-free Survival (PFS) is defined as the treated subjects without progression or occurrence of death due to any cause. PFS is defined as time from first dose to either first observation of progressive disease (PD) (according to Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1) or occurrence of death due to any cause up to 63 days following the last response assessment (or from start of treatment for subjects without a response assessment), whichever occurs first. In subjects without a progression date or with a death date more than 63 days after the last tumor assessment, the PFS time will be censored on the date of last tumor assessment. Subjects with no tumor assessment available and who have neither progressed nor died will be censored on the day of start of therapy. PFS rate will be assessed using Kaplan Meier method.
- Percentage of Subjects with Progression-free Survival (PFS) at 6 months: investigator-read assessment [ Time Frame: 6 months ]
- Percentage of Subjects with Progression-free Survival (PFS) at 3 and 9 months: independent- and investigator-read assessment [ Time Frame: 3 and 9 months ]
- Percentage of Subjects with Overall Response [ Time Frame: Up to 1 year ]The overall response is defined as achieving complete response (CR) or partial response (PR) as the best overall response according to RECIST Version 1.1. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Duration of Response [ Time Frame: Up to 1 year ]The duration of response is defined as time from date of first response to date of disease progression (according to RECIST Version 1.1) or death, estimated using the Kaplan-Meier method.
- Percentage of Subjects with 12-month Survival [ Time Frame: Up to 12 months after last subject's first dose ]The overall survival (OS) is defined (in months) as the time from start of therapy to occurrence of death due to any cause: (date of death or last date known to be alive - date of start of therapy + 1) / 30.4375. For subjects not known to be deceased at time of analysis, the time between the date of start of therapy and date of last contact or date lost to follow-up will be calculated and used as a censored observation in the analysis. If this date is after the data cut-off, subjects will be censored at the date of data cut-off.
- Number of Subjects with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days post-last administration of study drug ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255110
|Study Director:||Medical Responsible||Merck Serono Co., Ltd., Japan|