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Trial record 2 of 5 for:    PF-06946860

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803305
Recruitment Status : Completed
First Posted : March 17, 2021
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 15, 2021
First Posted Date  ICMJE March 17, 2021
Last Update Posted Date September 7, 2022
Actual Study Start Date  ICMJE May 11, 2021
Actual Primary Completion Date April 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2021)
  • 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.
  • 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.
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Week 6 ]
    Incidence of adverse events
  • Incidence of laboratory abnormalities [Safety and Tolerability] [ Time Frame: Week 6 ]
    Incidence of laboratory abnormalities
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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, at Weeks 1, 2, 3, 5 and 6.
  • 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, at Weeks 1, 2, 3, 4, 5 and 6
  • safety and tolerability of repeated subcutaneous administrations of PF-06946860 compared to placebo [ Time Frame: Week 6 ]
    Incidence of adverse events
  • safety and tolerability of repeated subcutaneous administrations of PF-06946860 compared to placebo [ Time Frame: Week 6 ]
    Incidence of laboratory abnormalities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential 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
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Loss of Appetite
  • Fatigue
  • Cachexia
  • Anorexia
Intervention  ICMJE
  • Drug: PF-06946860
    subcutaneous injection
  • Drug: Placebo for PF-06946860
    subcutaneous injection
Study Arms  ICMJE
  • Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
    subcutaneous injection
    Intervention: Drug: PF-06946860
  • Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
    subcutaneous injection
    Interventions:
    • Drug: PF-06946860
    • Drug: Placebo for PF-06946860
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2022)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2021)
40
Actual Study Completion Date  ICMJE August 9, 2022
Actual Primary Completion Date April 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 advanced.
  • Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
  • Meets any of the following criteria at Randomization:

    • Not currently receiving antineoplastic therapy
    • On standard of care systemic antineoplastic therapy or treatment without curative intent
  • Signed informed consent.

Key Exclusion Criteria:

  • 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, HIV or participants with known AIDS-related illness
  • inadequate renal or liver function.
  • Women who are pregnant or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04803305
Other Study ID Numbers  ICMJE C3651010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP