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Other or Multiple Cancer Types
Ponsegromab | PF-06946860 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Australia, Israel, Japan, Puerto Rico, Taiwan
for more information at clinicaltrials.gov
EXPERIMENTAL: Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
DRUG: ponsegromab
Double-Blind ponsegromab Treatment
EXPERIMENTAL: Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
DRUG: ponsegromab
Double-Blind ponsegromab Treatment
PLACEBO_COMPARATOR: Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
DRUG: placebo
Double-Blind placebo Treatment
Key inclusion Criteria:
Percent change from baseline in body weight for ponsegromab compared to placebo
Baseline, Week 12
Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores
Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.
Baseline, Week 12
Change from baseline in non-sedentary physical activity time
measured by wearable Digital Health Technology watch
Baseline, Week 12
Overall survival
Outcome defined as the time from randomization to occurrence of all-cause death
Randomization through completion of Phase 3 of the study, an average of 1 year
Change from baseline in body weight (kg)
Baseline, Week 12 and up to Week 52
Change from baseline at Week 12 in physical activity as measured by total vector magnitude
measured by wearable Digital Health Technology watch
Baseline, Week 12
Effect on progression free survival
determined by Blinded Independent Central Review
Randomization through completion of Phase 3 of the study, an average of 1 year
Effect on objective response rate
determined by Blinded Independent Central Review
Baseline, Week 52
Effect on disease control rate
determined by Blinded Independent Central Review
Baseline, Week 52
Effect on duration of response
determined by Blinded Independent Central Review
Baseline, Week 52
Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3)
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in intermuscular adipose area and radiodensity at L3
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in subcutaneous adipose area and radiodensity at L3
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in visceral adipose area and radiodensity at L3
measured by CT (or MRI) scan
Baseline, Week 12
Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study.
Baseline, Week 12 and up to Week 52
Number of participants with laboratory test abnormalities.
Baseline, Week 12 and up to Week 52
Number of participants with vital signs abnormalities.
Baseline, Week 12 and up to Week 52
Change in physical function, assessed on participant completed Patient-Reported Outcomes Measurement Information System Physical Function (version 8c) questionnaire.
The overall score range for the T-score is 0-100. Higher scores indicate better outcome.
Baseline, Week 12 and up to Week 52
Change in fatigue, as assessed on participant completed Patient-Reported Outcomes Measurement Information System - Fatigue (version 7a) questionnaire.
The overall score range for the T-score is 29.4-83.2. Lower scores indicate better outcome.
Baseline, Week 12 and up to Week 52
Occurrence of the TEAEs of nausea, vomiting, loss of appetite, or fatigue.
Baseline, Week 52
Severity of the adverse events of nausea, vomiting, loss of appetite, or fatigue by maximum grade.
Baseline, Week 52
Occurrence of chemotherapy dosing changes (including dosing reductions, dosing interruptions, and dosing discontinuations) due to occurrence of the TEAEs of nausea, vomiting, loss of appetite, or fatigue
Baseline, up to Week 52
Tumor status
Assessment of tumor response to treatment as determined by Blinded Independent Central Review assessment per RECIST 1.1 using CT scan (or MRI)
Baseline, Week 12 and up to Week 52
982
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06989437
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