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Ponsegromab for Cachexia (PROACC-1 Trial)

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer
Cachexia defined by Fearon criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

PROACC-1 Trial Summary

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

Who is the study for?
This trial is for adults with non-small cell lung, pancreatic, or colorectal cancer who are experiencing cachexia (significant weight loss due to illness) as defined by Fearon criteria. They must have elevated GDF-15 protein levels and be able to consent to the study. People with tube feedings, other causes of cachexia, severe allergies to monoclonal antibodies, or poor kidney/liver function cannot join.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a drug called Ponsegromab in comparison to a placebo in patients suffering from cancer-related cachexia. Participants will either receive Ponsegromab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects of Ponsegromab may include allergic reactions similar to those seen with other monoclonal antibody therapies. Specific side effects are not listed but generally could range from mild infusion-related reactions to more serious organ-specific inflammation.

PROACC-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with lung, pancreatic, or colorectal cancer.
Select...
I have significant weight loss and muscle loss.
Select...
I'm sorry, I need more context to accurately provide a summary for this criterion. Could you please provide more information or context?
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I have been diagnosed with lung, pancreatic, or colorectal cancer.
Select...
I am capable of limited self-care.

PROACC-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in body weight for ponsegromab compared to placebo
Secondary outcome measures
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 physical activity as measured with remote digital sensors
Electrocardiogram
+4 more

PROACC-1 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab medium dose subcutaneous injection every 4 weeks
Group II: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab low dose subcutaneous injection every 4 weeks
Group III: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab high dose subcutaneous injection every 4 weeks
Group IV: Double-Blind Placebo Treatment followed by Open-Label ponsegromab TreatmentPlacebo Group1 Intervention
Match placebo subcutaneous injection every 4 weeks

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,562 Previous Clinical Trials
10,906,953 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,349 Total Patients Enrolled

Media Library

Placebo for Ponsegromab Clinical Trial Eligibility Overview. Trial Name: NCT05546476 — Phase 2
Colorectal Cancer Research Study Groups: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment, Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment, Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment, Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
Colorectal Cancer Clinical Trial 2023: Placebo for Ponsegromab Highlights & Side Effects. Trial Name: NCT05546476 — Phase 2
Placebo for Ponsegromab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546476 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the risk profile associated with ponsegromab?

"The safety of ponsegromab was assessed at a 2, as there is existing evidence verifying its security although no clinical data exists to demonstrate the efficacy."

Answered by AI

Is enrollment open for this experiment?

"Per clinicaltrials.gov, this experiment is not currently seeking to enroll any new participants. The trial was initially advertised on November 4th 2022 and its last update occurred October 27th 2022. Though the study doesn't have openings at present, there are numerous other trials that do require volunteers right now - 1477 in total."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Duke Cancer Institute
Baptist Health Lexington
Carta - Clinical Associates in Research Therapeutics of America, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~10 spots leftby May 2024