ponsegromab for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal Cancer+5 Moreponsegromab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new drug is effective, safe, and tolerable for treating cancer-related cachexia and elevated GDF 15 levels.

Eligible Conditions
  • Colorectal Cancer
  • Cachexia
  • Fatigue
  • Non-small Cell Lung Cancer
  • Anorexia
  • Pancreatic Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 12

Week 12
Electrocardiogram
Incidence of adverse events
Incidence of lab abnormalities
Incidence of vital sign abnormalities
baseline, Week 12
Change from baseline in anorexia/appetite; Nausea and vomiting; and Fatigue as measured by the Cancer Related Cachexia Symptom Diary (CRCSD)
Change from baseline in body weight for ponsegromab compared to placebo
Change from baseline in physical activity as measured with remote digital sensors
change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab ...
1 of 4
Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab T...
1 of 4
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegroma...
1 of 4
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
1 of 4

Experimental Treatment

Non-Treatment Group

168 Total Participants · 4 Treatment Groups

Primary Treatment: ponsegromab · Has Placebo Group · Phase 2

Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
Drug
Experimental Group · 1 Intervention: ponsegromab · Intervention Types: Drug
Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
Drug
Experimental Group · 1 Intervention: ponsegromab · Intervention Types: Drug
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
Drug
Experimental Group · 1 Intervention: ponsegromab · Intervention Types: Drug
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
Drug
PlaceboComparator Group · 1 Intervention: Placebo for ponsegromab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

PfizerLead Sponsor
4,303 Previous Clinical Trials
7,144,109 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,854,015 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a documented diagnosis of non-small cell lung, pancreatic, colorectal cancer.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Carta - Clinical Associates in Research Therapeutics of America, LLC100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%