Wednesday, December 21, 2022 The permanent trial closure of the IND217 : A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours trial. This trial was led by the C17 Council – Edmonton Clinical Health Academy (ECHA) and CCTG collected data only. Objectives: Primary Objective: To determine the recommended phase II dose and maximum tolerated dose of LDM topotecan in combination with pazopanib. Secondary Objectives: Anti-tumour activity in solid tumours and specifically in neuroblastoma and rhabdomyosarcoma. Characterize the pharmacokinetic profile as well as drug-drug interactions, and assess the anti-angiogenic activity. For more information please visit the CCTG IND217 members trial page. Permanent trial closure of the MA32F: Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer - NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project trial. Objectives: - Determine the biological correlates of fatigue in breast cancer patients in the years following MA32 randomization and initiation of metformin or placebo. - Determine if specific SNPs in the promoter regions of IL-1 and IL-6 are associated with circulating markers of inflammation and fatigue in the years following MA32. - Determine which RNA gene expression pathways are associated with fatigue in metformin-treated patients and how do they relate to RNA gene expression pathways in untreated patients. - Determine the biological and behavorial predictors of fatigue in breast cancer patients in the years post-randomization. - Determine if metformin will be associated with reductions in inflammatory markers and corresponding decreases in fatigue. For more information please visit the CCTG MA32F members trial page. Permanent trial closure of the SRC7 (Alliance A091105): A Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF), has been permanently closed/terminated by the lead group. Objectives: Primary Objective: To compare the progression-free survival (PFS) rates of patients with DT/DF who receive either sorafenib or placebo using a double-blinded randomized phase III study. Secondary Objectives: To assess toxicity, to assess time to surgical intervention, to assess tumor response rates and survival. For more information please visit the CCTG SRC7 members trial page.
