NCT02306161

Clinical Trial Information


Trial Number: NCT02306161 (ClinicalTrials.gov)
Disease Type:
  • Miscellaneous Neoplasm - Metastases, Distant (excluding specified site of origin)
Trial Title:
Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Study ID:
AEWS1221
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT02306161-D5 D5: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D5, provides the information on the crossover effect on OS in the supplemental materials. There is one row per patient and time-period prior to the discontinuation of ganitumab and after, if applicable, to reflect the time at risk before and after, discontinuation.
NCT02306161-D4 D4: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D4, provides the information on the crossover effect on EFS in the supplemental materials. There is one row per patient and time-period prior to the discontinuation of ganitumab and after, if applicable, to reflect the time at risk before and after, discontinuation.
NCT02306161-D3 D3: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D3, provides the information for supplemental table A5: ganitumab serum concentrations for the first ten patients with metastatic Ewing sarcoma. There is one row per patient and time point where a serum ganitumab concentration was measured with result.
NCT02306161-D2 D2: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D2, provides the information for table 2: toxicity incidence (non-hematologic toxicities occurring in 10% or greater fraction of patients and toxicities of interest regardless of incidence). There is a row per patient, toxicity term, grade, and experienced-toxicity (yes or no).
NCT02306161-D1 D1: There are 5 datasets associated with the PMID 36669140: NCT02306161-D1 through NCT02306161-D5. This dataset, NCT02306161-D1, provides the information for the CONSORT diagram, text of the document, table 1: patient characteristics, figure 3: Kaplan-Meier curves, supplemental table A1: sites of metastasis, supplemental table A2: mode of primary site local control, and the estimates in supplemental tables A3 and A4: EFS and cumulative incidence of first progression, respectively. There is one row per patient.