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Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 (PROACC-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05546476
Recruitment Status : Recruiting
First Posted : September 19, 2022
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Pancreatic Cancer Colorectal Cancer Loss of Appetite Fatigue Cachexia Drug: ponsegromab Drug: Placebo for ponsegromab Phase 2

Detailed Description:

A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo.

Assessments include:

  • Body weight measurements
  • Measure the impact of ponsegromab compared to placebo on physical activity.
  • Measure the impact of ponsegromab compared to placebo on appetite, nausea and fatigue questionnaires
  • Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF-15
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind for 12-week double-blind treatment period followed by an up to 1 year optional open-label treatment period
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 21, 2022
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
ponsegromab low dose subcutaneous injection every 4 weeks
 Drug: ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
Match placebo subcutaneous injection every 4 weeks
 Drug: Placebo for ponsegromab
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Experimental: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
ponsegromab medium dose subcutaneous injection every 4 weeks
 Drug: ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Experimental: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
ponsegromab high dose subcutaneous injection every 4 weeks
 Drug: ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in body weight for ponsegromab compared to placebo [ Time Frame: baseline, Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in physical activity as measured with remote digital sensors [ Time Frame: baseline, Week 12 ]
    evaluation of physical activity (Sedentary, light and moderate) and gait speed.

  2. change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores [ Time Frame: baseline, Week 12 ]
    FACT-G score sums 27 items; ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.

  3. Change from baseline in anorexia/appetite; Nausea and vomiting; and Fatigue as measured by the Cancer Related Cachexia Symptom Diary (CRCSD) [ Time Frame: baseline, Week 12 ]
    Self-reported questionnaire that measures severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue.

  4. Incidence of adverse events [ Time Frame: Week 12 ]
  5. Incidence of lab abnormalities [ Time Frame: Week 12 ]
  6. Incidence of vital sign abnormalities [ Time Frame: Week 12 ]
  7. Incidence of ECG abnormalities [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer
  • Cachexia defined by Fearon criteria of weight loss
  • Serum GDF-15 concentrations
  • Signed informed consent
  • ECOG PS ≤3

Key Exclusion Criteria:

  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
  • Current active reversible causes of decreased food intake.
  • Cachexia caused by other reasons.
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
  • inadequate renal or liver function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05546476


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05546476    
Other Study ID Numbers: C3651003
2022-003016-87 ( EudraCT Number )
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
cancer
anorexia
cachexia
 weight loss
loss of appetite
fatigue
Additional relevant MeSH terms:
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Wasting Syndrome
Fatigue
Cachexia
Anorexia
Weight Loss
Body Weight Changes
 Body Weight
Thinness
Metabolic Diseases
Nutrition Disorders
Signs and Symptoms, Digestive