Clinical trial NCT04803305: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
timeFrame: Baseline, Weeks 1, 2, 3, 5 and 6
measure: Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
measure: Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
timeFrame: Day 1 through Week 6 (for a period of 6 weeks)
measure: Number of Participants With Laboratory Test Abnormalities in Part A
timeFrame: Days 1, 22 and 43
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group (THO)
state: California
city: Camarillo
country: United States
facility: Ventura County Hematology- Oncology Specialists
state: California
city: Los Angeles
country: United States
facility: Cedars- Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Ventura
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Wheat Ridge
country: United States
facility: Lutheran Medical Center
state: Colorado
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Bozeman
country: United States
facility: Bozeman Health Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Product Center (IPC)
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Longview Cancer Center
state: Texas
city: Paris
country: United States
facility: Texas Oncology-Paris
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Tyler
state: Texas
city: Charlottesville
country: United States
facility: Cancer Center IDS Pharmacy
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Charlottesville
country: United States
facility: UVA Health System; Attention: GI Team
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Gig Harbor
country: United States
facility: MultiCare Regional Cancer Center - Gig Harbor Medical Park
state: Washington
city: Moses Lake
country: United States
facility: Moses Lake Clinic
state: Washington
city: Puyallup
country: United States
facility: MultiCare Regional Cancer Center - Puyallup
state: Washington
city: Spokane Valley
country: United States
facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital
state: Washington
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: