Clinical Trial Search

Primary: Progression-free Survival (PFS) Assessed 12 Weeks After Start of Treatment — 54.1; 46.2 percentage of participants

Primary: Progression Free Survival at 12 Weeks — 66; 57.2 percentage of particpants

Primary: Overall Survival (OS) — 13.73; 13.14 Months

Primary: Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 2.83; 2.07 Months — p=0.0114

Primary: 12-week Progression Free Rate — 68.29 percentage of participants

Primary: Number of Participants Who Were Progression Free — 12 Participants

Primary: Progression-free Survival (PFS) (Arm 1 Only) — 5.48 months

Primary: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment — 20; 40 Percentage of participants

Primary: Progression-free Survival (PFS) — 8.18; 8.38; 7.16 Months — p=0.0956

Primary: Percentage of Participants in Objective Response at 6 Months — 0.0; 0.0; 0.0; 6.7 percentage of participants

Primary: The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per…

Primary: Percentage of Participants With Pathological Complete Response (pCR) — 13 percentage of participants

Primary: Overall Response Rate — 0; 2 Participants

Primary: 12-week Progression Free Survival (PFS) — 69.6; 36.8; 52.6 percentage of participants

Primary: Response Rate (Per RECIST 1.1) — 1 Participants

Primary: Number of Patients With Dose Limiting Toxicities. — 0; 1; 0 Participants

Primary: Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients) — 16.89; 10.42 percentage of participants

Primary: The Objective Response Rate (ORR) Based on RECIST 1.1 — 6 Participants

Primary: Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST — 1; 0; 0; 0 participants

Primary: Overall Objective Response — 5; 22; 8 participants

Primary: Overall Survival (OS) — 20.37; 19.75 Months — p=0.6945

Primary: Progression-free Survival (PFS) — 7.0; 20.0 weeks — p=<0.001

Primary: Number of Participants With Overall Response (OR) — 1 participants

Primary: Overall Objective Response — 1; 21; 26 participants

Primary: Time to Progression- Independent Review — 3.7; 2.3 months — p=0.0302

Primary: Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) — 4; 1; 5; 0 participants

Primary: Objective Response (Confirmed, Complete and Partial) — 1; 0; 1; 8 participants

Primary: Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) — 1; 4; 3 Participants

Primary: Confirmed Overall Response Rate Per the RECIST 1.1 Criteria — 0 percentage of patients

Primary: Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP. — 0.50 mg/m^2