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Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia

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ClinicalTrials.gov Identifier: NCT04803305
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Pancreatic Cancer Colorectal Cancer Prostate Cancer Breast Cancer Ovarian Cancer Loss of Appetite Fatigue Cachexia Anorexia Drug: PF-06946860 Drug: Placebo for PF-06946860 Phase 1

Detailed Description:

A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously).

During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart.. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo.

Assessments include:

  • Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
  • Body weight measurements
  • Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
Primary Purpose: Treatment
Official Title: A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO ASSESS THE EFFECT OF REPEATED SUBCUTANEOUS ADMINISTRATION OF PF-06946860 ON APPETITE IN PARTICIPANTS WITH ADVANCED CANCER AND ANOREXIA, FOLLOWED BY AN 18-WEEK OPEN-LABEL TREATMENT PERIOD
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : May 12, 2022
Estimated Study Completion Date : June 8, 2022


Arm Intervention/treatment
Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
subcutaneous injection
Drug: PF-06946860
subcutaneous injection

Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
subcutaneous injection
Drug: PF-06946860
subcutaneous injection

Drug: Placebo for PF-06946860
subcutaneous injection




Primary Outcome Measures :
  1. effect of PF 06946860 compared to placebo on appetite [ Time Frame: Week 4 ]
    Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.


Secondary Outcome Measures :
  1. effect of PF 06946860 compared to placebo on appetite [ Time Frame: Weeks 1, 2, 3, 5 and 6 ]
    Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.

  2. effect of PF 06946860 compared to placebo on fatigue [ Time Frame: Weeks 1, 2, 3, 4, 5 and 6. ]
    Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Fatigue score based on 11-point numerical rating scale.

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 6 ]
    Incidence of adverse events

  4. Incidence of laboratory abnormalities [Safety and Tolerability] [ Time Frame: Week 6 ]
    Incidence of laboratory abnormalities



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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, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered incurable.
  • Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
  • Meets any 1 of the following criteria at Randomization:

    • Not currently receiving antineoplastic therapy
    • On third line systemic antineoplastic therapy
    • Receiving chemotherapy or immunotherapy treatment which is considered to be without curative intent.
    • On a stable regimen of systemic antineoplastic therapy.
  • Signed informed consent.

Key Exclusion Criteria:

  • Other forms of cancer not listed in Inclusion Criterion for which treatment has been received in the past 6 months
  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
  • Current active reversible causes of decreased food intake.
  • Current, severe gastrointestinal disease
  • Participants with known symptomatic brain metastases requiring steroids.
  • Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV. Confirmed positive test for HIV.
  • Elevated blood pressure uncontrolled by medications.
  • inadequate renal or liver function.
  • Women who are pregnant or breast-feeding

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): NCT04803305


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

Locations
Show Show 49 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04803305    
Other Study ID Numbers: C3651010
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Anorexia
Cachexia
Signs and Symptoms, Digestive
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders