PROTOCOL SYNOPSIS Clause Samples
PROTOCOL SYNOPSIS. Title: An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003 Protocol Number: BA058-05-005 Test Drug: Alendronate Please note that the name of BA058 Injection 80 µg has been changed to Abaloparatide-SC, therefore the name has been changed throughout the document. The primary objective of this study is to collect clinical information regarding six months of treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with Abaloparatide-SC or Placebo in Study BA058-05-003. Safety data will be obtained via clinical, laboratory and radiologic assessments. Following the initial six months of treatment in the study, subjects will then enter the long-term observational phase of the study during which subjects will continue to receive alendronate treatment for an additional 18 months (for a total of 24 months). The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with Abaloparatide-SC/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of treatment with Abaloparatide-SC/Placebo. The analysis performed at six months of this Extension Study will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Vertebral fractures based on radiologic assessments will also be analyzed at Month 24. Additional analyses for other endpoints will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.
PROTOCOL SYNOPSIS. Study Title The PISCES Study: A Multicenter Phase 2, Open-Label Trial of Intratumoral pIL-12 plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment Protocol No. OMS-I103 [*****] [*****] Study Phase 2 Therapeutic Indication Intratumoral injection of plasmid interleukin-12 followed by electroporation (ImmunoPulse® IL-12), in combination with an anti-programmed cell death protein 1 (PD-1) antibody pembrolizumab, is indicated for the treatment of unresectable or metastatic melanoma. Study Objectives ● To assess efficacy of best overall response rate (B▇▇▇) by independent central review based on RECIST v1.1 over 24 weeks (end of Core study) of intratumoral pIL-12-EP in combination with pembrolizumab (IV) (collectively ‘the combined treatment’) in patients with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with other approved checkpoint inhibitor. ● To assess safety and tolerability of the combined treatment in patients with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with other approved checkpoint inhibitor). ● To assess duration of response (DOR), objective response rate (O▇▇), immune B▇▇▇ (iBORR), progression free survival (PFS), immune PFS (iPFS), and overall survival (OS) of combination therapy; ● [*****] Investigational Product Route and Dosage Form Plasmid interleukin-12 (pIL-12) will be injected intratumorally (on Days 1, 5 and 8 every 6 weeks) [*****] Pembrolizumab will be administered at a dose of 200 mg [*****]
PROTOCOL SYNOPSIS. Study Design Text revised: “…Randomization will be stratified by age (12-14 vs 15-1716 years old) and gender ”
PROTOCOL SYNOPSIS. Study Population: Key Exclusion Criteria Text added: “…History of bipolar disorder or psychosis, greater than one lifetime episode of major depressive disorder, depression of moderate or greater severity...”
PROTOCOL SYNOPSIS. Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
PROTOCOL SYNOPSIS. Title: An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003 Protocol Number: BA058-05-005 Test Drug: BA058 Injection
PROTOCOL SYNOPSIS