Yondelis trial

The trial measured the amount of time from the start of the trial when patients were living with the cancer up until when the cancer worsened called progression-free survival.

Patients were required to have unresectable, locally advanced or metastatic leiomyosarcoma or liposarcoma dedifferentiated, myxoid round cell, or pleomorphic and previous treatment with an anthracycline- and ifosfamide-containing regimen or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen. Randomization was stratified by subtype of soft tissue sarcoma leiomyosarcoma vs.

EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial. The effects of the active drug or treatment are compared to the effects of the placebo. Demographic subsets include sex, race, and age groups.

Back to Drug Trials Snapshots. Resources for Information Approved Drugs. What are the benefits of this drug results of trials used to assess efficacy? Overall Survival [ Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years ] The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.

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The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

This is a randomized individuals assigned to study treatment by chance , open - label identity of assigned study drug will be known , active - controlled study in adult female patients with platinum-sensitive advanced - relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum - based chemotherapy.

Approximately participants will be enrolled. During the treatment phase, patients will receive study drug infusions according to 21 - day cycles in Arm A and 28 - day cycles in Arm B. Treatment will continue until the occurrence of disease progression or unacceptable treatment toxicity, or until 2 cycles after assessment of a complete response CR.

Disease assessments, including assessments for patients who discontinue treatment for reasons other than disease progression, will be performed until disease progression, the start of subsequent anticancer therapy, withdrawal of consent, or the clinical cutoff date. Collection of survival status will continue until at least deaths have been observed or until the clinical data cutoff date. Serial pharmacokinetic PK samples will be collected in a subset of patients who voluntarily consent to the PK portion of the study.

Safety will be monitored throughout the study. An interim analysis of overall survival OS will be performed after approximately participants have died. The final analysis of OS will occur when approximately deaths have been observed or until the clinical cutoff date. All study participants Arm A or Arm B currently on study who, in the opinion of the investigator, are deriving clinical benefit may continue treatment with single-agent DOXIL as per the local standard of care.

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Trabectedin. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria.

If the optimal dose found in Part 1 is below 1. 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.

FDA Resources. Arms and Interventions. Outcome Measures. 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. PFS is defined as the time from randomization to the occurrence of disease progression or death, whichever occurs first.

Time-to-progression TTP is defined as the time between dosing and disease progression. Time-to-progression TTP is defined as the time between randomization and disease progression.

Objective Response Rate ORR is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.

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. Pharmacokinetic parameter Cmax of trabectedin will be determined. Pharmacokinetic parameter AUC of trabectedin will be determined. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Contacts and Locations. Information from the National Library of Medicine 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.