Clinical Trial Search

Primary: Event Free Survival (EFS) — 0.6255; 0.5874 Probability

Primary: Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry — 87; 67 Estimated percentage of participants

Primary: Number of Patients With Complete or Partial Response Assessed by RECIST Criteria — 63 percentage of participants

Primary: Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment — 0.9390 Proportion of Participants

Primary: Percentage of Participants With Objective Response — 0; 0; 0 percentage of participants

Primary: Event Free Survival Probability — 0.23; 0.43 Probability — p=0.0124

Primary: Probability for Event Free Survival. — 0.8984; 0.7647; 0.6079; 0.4873 Probability of EFS at 5 years

Primary: Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up — 10.9 Percentage of patients

Primary: Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment — 52.5; 68.9 percentage of participants

Primary: Objective Response by RECIST Criteria v 1.1 — 10; 10; 0; 0 participants

Primary: Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment — 17.7 percentage of participants

Primary: Number of Participants With Engraftment — 23 Participants

Primary: Percentage of Participants With Overall Tumor Response (Response Rate) — 0; 0; 0; 0 Percentage of Participants

Primary: Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled — 95 percentage of lesions

Primary: Bone Density (Low Areal Bone Mineral Density (aBMD)) — -1.3; -0.9; -2.4; -1.2 z-score

Primary: Response (Complete Response [CR] and Partial Response [PR]) — 1; 0; 0; 0 participants

Primary: Best Overall Response Rates by Week 16 (ITT) — 0; 0; 0; 0 percentage of participants — p=0.1

Primary: Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1 — 0.00; 6.25; 0.00; 0.00 Percent of participants

Primary: Number of Patients With Abdominal Recurrence or Death — 72; 73; 61; 60 Participants — p=0.955

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

Primary: Best Anatomical Tumor Response — 0; 2; 22; 30 participants

Primary: Progression Free Survival (PFS) — NA; NA Months

Primary: Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy. — 13 percentage of pt with a partial response

Primary: Objective Response Rate — 0 percentage of participants

Primary: Rate of Complete Tumor Necrosis — 4 Participants

Primary: Objective Tumor Response (Complete and Partial) — 2 Participants

Primary: Number of Patients With Dose Limiting Toxicities. — 0; 1; 0 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: Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay — 0; 15 Participants — p=0.043

Primary: Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST). — 10; 11; 11; 11 participants