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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

Primary Purpose

Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06946860
Placebo for PF-06946860
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CARTI Cancer Center
  • Tower Hematology Oncology Medical Group (THO)
  • Ventura County Hematology- Oncology Specialists
  • Cedars- Sinai Medical Center
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • Cedars-Sinai Medical Center
  • Ventura County Hematology Oncology Specialists
  • Providence Medical Foundation
  • Ventura County Hematology-Oncology Specialists
  • Lutheran Medical Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Bozeman Health Cancer Center
  • Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
  • Bozeman Health Deaconess Hospital
  • Mary Crowley Cancer Research
  • The University of Texas MD Anderson Cancer Center
  • US Oncology Investigational Product Center (IPC)
  • Texas Oncology - Longview Cancer Center
  • Texas Oncology-Paris
  • Texas Oncology- Tyler
  • Cancer Center IDS Pharmacy
  • University of Virginia Cancer Center
  • UVA Health System; Attention: GI Team
  • University of Virginia Health System
  • MultiCare Regional Cancer Center - Auburn
  • MultiCare Regional Cancer Center - Gig Harbor Medical Park
  • Moses Lake Clinic
  • MultiCare Regional Cancer Center - Puyallup
  • Medical Oncology Associates, PS (dba Summit Cancer Centers)
  • MultiCare Institute for Research & Innovation
  • MultiCare Regional Cancer Center - Tacoma
  • Wenatchee Valley Hospital
  • The Ottawa Hospital Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment

Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment

Arm Description

subcutaneous injection

subcutaneous injection

Outcomes

Primary Outcome Measures

effect of PF 06946860 compared to placebo on appetite
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

effect of PF 06946860 compared to placebo on appetite
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
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]
Incidence of adverse events
Incidence of laboratory abnormalities [Safety and Tolerability]
Incidence of laboratory abnormalities

Full Information

First Posted
March 15, 2021
Last Updated
December 12, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04803305
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer, Breast Cancer, Ovarian Cancer, Loss of Appetite, Fatigue, Cachexia, Anorexia
Keywords
cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
Arm Type
Experimental
Arm Description
subcutaneous injection
Arm Title
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
Arm Type
Placebo Comparator
Arm Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
PF-06946860
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo for PF-06946860
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
effect of PF 06946860 compared to placebo on appetite
Description
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
effect of PF 06946860 compared to placebo on appetite
Description
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
Time Frame
Weeks 1, 2, 3, 5 and 6
Title
effect of PF 06946860 compared to placebo on fatigue
Description
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Fatigue score based on 11-point numerical rating scale.
Time Frame
Weeks 1, 2, 3, 4, 5 and 6.
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of adverse events
Time Frame
Week 6
Title
Incidence of laboratory abnormalities [Safety and Tolerability]
Description
Incidence of laboratory abnormalities
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CARTI Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tower Hematology Oncology Medical Group (THO)
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ventura County Hematology- Oncology Specialists
City
Camarillo
State/Province
California
ZIP/Postal Code
93010
Country
United States
Facility Name
Cedars- Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Bozeman Health Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Health Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology Investigational Product Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology - Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology-Paris
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Facility Name
Texas Oncology- Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Center IDS Pharmacy
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
UVA Health System; Attention: GI Team
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
MultiCare Regional Cancer Center - Auburn
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
MultiCare Regional Cancer Center - Gig Harbor Medical Park
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
Moses Lake Clinic
City
Moses Lake
State/Province
Washington
ZIP/Postal Code
98837
Country
United States
Facility Name
MultiCare Regional Cancer Center - Puyallup
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Medical Oncology Associates, PS (dba Summit Cancer Centers)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Regional Cancer Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wenatchee Valley Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3651010
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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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