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C3651003 A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510446-24-00
Acronym
C3651003
Enrollment
53
Registered
2024-03-29
Start date
2023-05-30
Completion date
2025-04-23
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer cachexia

Brief summary

Change from baseline body weight at Week 12.

Detailed description

Change from baseline in each of the physical activity and gait endpoints measured with remote digital sensors at Week 12: Moderate to vigorous physical activity time; Sedentary activity time; Non sedentary activity time; Total vector magnitude; Mean activity level during M6min; Mean gait speed; 95th percentile gait speed., Change from baseline in FAACT sub-scale scores at Week 12: FAACT-ACS; FAACT-5IASS., Change from baseline score for the questions from the CRCSD at Week 12 related to: Anorexia/appetite; Nausea and vomiting; Fatigue., Incidence of adverse events, safety laboratory tests, vital signs and ECG abnormalities

Interventions

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline body weight at Week 12.

Secondary

MeasureTime frame
Change from baseline in each of the physical activity and gait endpoints measured with remote digital sensors at Week 12: Moderate to vigorous physical activity time; Sedentary activity time; Non sedentary activity time; Total vector magnitude; Mean activity level during M6min; Mean gait speed; 95th percentile gait speed., Change from baseline in FAACT sub-scale scores at Week 12: FAACT-ACS; FAACT-5IASS., Change from baseline score for the questions from the CRCSD at Week 12 related to: Anorexia/appetite; Nausea and vomiting; Fatigue., Incidence of adverse events, safety laboratory tests, vital signs and ECG abnormalities

Countries

Bulgaria, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026