Advanced or Metastatic Liposarcoma or Leiomyosarcoma Clinical Trial
Official title:
Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
| Verified date | July 2018 |
| Source | Xian-Janssen Pharmaceutical Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | October 11, 2016 |
| Est. primary completion date | October 11, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically proven, unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma - Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen - Measurable disease at baseline in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 - Adequate recovery from prior therapy; all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute - Adequate organ function and hepatic function Exclusion Criteria: - Prior exposure to trabectedin (both Part 1 and Part 2) or dacarbazine (Only Part 2) - Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent - Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix) - Known central nervous system metastasis - Active or symptomatic viral hepatitis or chronic liver disease |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Xian-Janssen Pharmaceutical Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | From the date of dosing until 21days after the date of last patient enrolled | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | Part 1: Time-to-progression (TTP) | Time-to-progression (TTP) is defined as the time between dosing and disease progression. | 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 | |
| Secondary | Part 2: Time-to-progression (TTP) | Time-to-progression (TTP) is defined as the time between randomization and disease progression. | 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 | |
| Secondary | 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. | From date of dosing until the date of best response, as assessed up to 18 months after the last patient enrollment | |
| Secondary | 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. | From date of dosing until the date of best response, as assessed up to 6 months after the last patient enrollment | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | Part 1: Observed maximum plasma concentration (Cmax) | Pharmacokinetic parameter Cmax of trabectedin will be determined | Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles | |
| Secondary | Part 1: Area under the plasma concentration-time curve (AUC) | Pharmacokinetic parameter AUC of trabectedin will be determined. | Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles |