Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

Part of paid clinical trials in Conway, Arkansas.

Sponsor
Pfizer
Study ID
NCT05546476
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ponsegromab — DRUG
    Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
  • Placebo for ponsegromab — DRUG
    Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Study Details

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Key Dates

Start date
Nov 21, 2022
Status verified
Jun 2026
Primary completion
Mar 13, 2024
Completion
Apr 23, 2025

Study Design

Enrollment
187 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
    ponsegromab low dose subcutaneous injection every 4 weeks
  • Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
    Match placebo subcutaneous injection every 4 weeks
  • Experimental: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
    ponsegromab medium dose subcutaneous injection every 4 weeks
  • Experimental: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
    ponsegromab high dose subcutaneous injection every 4 weeks

Primary Outcome Measure

Part A: Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (19)

FacilityCityStateZIPSite coordinators
CARTI ConwayConwayArkansas72034-
CARTI Cancer CenterLittle RockArkansas72205-
CARTI North Little RockNorth Little RockArkansas72117-
CARTI StuttgartStuttgartArkansas72160-
Pacific Cancer Medical Center INCAnaheimCalifornia92801-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Emad Ibrahim,MD,INC.RedlandsCalifornia92373-
Providence Medical FoundationSanta RosaCalifornia95403-
IU Health Arnett Cancer CenterLafayetteIndiana47904-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Tandem Clinical ResearchMarreroLouisiana70072-
Bozeman Health Deaconess HospitalBozemanMontana59715-
Oregon Health and Science UniversityPortlandOregon97239-
Oregon Health and Science University: Center for Health and Healing 1PortlandOregon97239-
Oregon Health and Science University: Center for Health and Healing 2PortlandOregon97239-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Carta - Clinical Associates in Research Therapeutics of America, LLCSan AntonioTexas78212-
Virginia Mason Medical CenterSeattleWashington98101-
Wenatchee Valley HospitalWenatcheeWashington98801-

Related coverage on Hipa.ai

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