A Phase 3 interventional study of Trabectedin and Dacarbazine in Advanced or Metastatic Liposarcoma or Leiomyosarcoma, sponsored by Xian-Janssen Pharmaceutical Ltd.. Completed at 2 sites in China. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Xian-Janssen Pharmaceutical Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).
The study is divided into 2 separate parts (ie, Part 1 and Part 2). Part 1 is a dose finding part (to find the optimal dose) of trabectedin for Chinese patients, and Part 2 is a multicenter, randomized (the study medication is assigned by chance), active-controlled (an active substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), parallel-group (a study comparing the response in two or more groups of patients receiving different interventions), open-label (all people know the identity of the intervention) bridging part comparing the efficacy and safety of the optimal dose of trabectedin with dacarbazine in the same population as in Part 1. The study (in both Part 1 and Part 2) will consist of a screening phase, a treatment phase and a follow-up phase. Part 1: Optimal dose (ie, maximum tolerated dose [MTD]) is determined from the following 3 dose levels: Dose level 1 (1.5 mg/m2), Dose level 2 (1.2 mg/m2), and Dose level 3 (1.0 mg/m2)of trabectedin. Cohorts of 6 patients will be treated at each dose level. To determine MTD, dose limiting toxicity (DLT; any pre-defined adverse event that occurs during the first cycle ie, Cycle 1) will be determined. In the first cohort of 6 patients, (a) if DLT is less than or equal to 1 at a dose level, it is considered as MTD (b) if DLT is greater than 2, patients will be de-escalated to next dose level (c) if DLT is equal to 2, 3 more patients will be included at that dose level and if there will be no DLT in those 3 patients, that dose level is considered as MTD. Part 2: If the optimal dose found in Part 1 is 1.5 mg/m2, approximately 48 patients will be randomly assigned to either the trabectedin (approximately 32 patients) or dacarbazine (approximately 16 patients) treatment group in Part 2. If the optimal dose found in Part 1 is below 1.5 mg/m2, 123 patients will be randomly assigned to either the trabectedin (approximately 82 patients) or dacarbazine (approximately 41 patients) treatment group. Safety will be evaluated by assessing adverse events, clinical laboratory test, multiple gated acquisition scans, electrocardiograms, vital signs, and physical examination throughout the study up to 30 days after the end of treatment.
147 studies on the registry are indexed under Leiomyosarcoma; 33 are open to participants now.
This study's enrollment of 16 is below the median of 45 across 121 interventional studies indexed under Leiomyosarcoma.
Browse Leiomyosarcoma studies →Xian-Janssen Pharmaceutical Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Trabectedin will be administered at a dose of 1.5, 1.2 or 1.0 mg/m2 as a 24-hour intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).
Drug: Trabectedin
Dacarbazine will be administered at a dose of 1 g/m2 as a longer than 30-minute intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).
Drug: Dacarbazine
Type=exact number, unit=mg/m2, number=1.5, 1.2 or 1.0, form=solution, route=intravenous infusion. Trabectedin will be administered on Day 1 of each 21-day treatment cycle.
Also known as: YONDELIS
Type=exact number, unit=g/m2, number=1, form=solution, route=intravenous infusion. Dacarbazine will be administered on Day 1 of each 21-day treatment cycle.
Part 1: Optimal dose level (Maximum tolerated dose [MTD]) of trabectidin
MTD (1.5, 1.2 or 1.0 mg/m2) is determined by assessing Dose Limiting Toxicity (DLT).
Time frame: From the date of dosing until 21days after the date of last patient enrolled
Part 1: Overall survival
Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.
Time frame: From the date of dosing upto 18 months after the last patient enrollment or 30 days after the last dose of study medication has been administered, whichever will be later
Part 2: Overall survival
Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.
Time frame: From the date of randomization until the required number of events has occurred (approximately 32 if 1.5mg/m2, or 82 with below 1.5mg/m2) as assessed approximately for 6 months after the last patient enrollment
Part 1: Progression free survival (PFS)
PFS is defined as the time from dosing to the occurrence of disease progression or death, whichever occurs first.
Time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment
Part 2: Progression free survival (PFS)
PFS is defined as the time from randomization to the occurrence of disease progression or death, whichever occurs first.
Time frame: From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment
Part 1: Time-to-progression (TTP)
Time-to-progression (TTP) is defined as the time between dosing and disease progression.
Time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment
Part 2: Time-to-progression (TTP)
Time-to-progression (TTP) is defined as the time between randomization and disease progression.
Time frame: From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment
Part 1: Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.
Time frame: From date of dosing until the date of best response, as assessed up to 18 months after the last patient enrollment
Part 2: Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.
Time frame: From date of dosing until the date of best response, as assessed up to 6 months after the last patient enrollment
Part 1: Duration of response (DR)
Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.
Time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed approximately up to 18 months after the last patient enrollment
Part 2: Duration of response (DR)
Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.
Time frame: From the date of randomization till the first documented disease progression or death whichever comes first, assessed approximately up to 6 months after the last patient enrollment
Part 1: Observed maximum plasma concentration (Cmax)
Pharmacokinetic parameter Cmax of trabectedin will be determined
Time frame: Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles
Part 1: Area under the plasma concentration-time curve (AUC)
Pharmacokinetic parameter AUC of trabectedin will be determined.
Time frame: Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Xian-Janssen Pharmaceutical Ltd.