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

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04803305

Collaborator

(none)

Enrollment

Locations

Arms

21.5

Anticipated Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

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

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

Anticipated Primary Completion Date :

Jan 27, 2023

Anticipated Study Completion Date :

Feb 23, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

effect of PF 06946860 compared to placebo on appetite [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

effect of PF 06946860 compared to placebo on appetite [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 [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] [Week 6]
Incidence of adverse events
Incidence of laboratory abnormalities [Safety and Tolerability] [Week 6]
Incidence of laboratory abnormalities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carti Cancer Center	Little Rock	Arkansas	United States	72205
2	Tower Hematology Oncology Medical Group (THO)	Beverly Hills	California	United States	90211
3	Ventura County Hematology- Oncology Specialists	Camarillo	California	United States	93010
4	Cedars- Sinai Medical Center	Los Angeles	California	United States	90048
5	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California	United States	90048
6	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
7	Ventura County Hematology Oncology Specialists	Oxnard	California	United States	93030
8	Providence Medical Foundation	Santa Rosa	California	United States	95403
9	Ventura County Hematology-Oncology Specialists	Ventura	California	United States	93003
10	Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
11	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46804
12	Bozeman Health Cancer Center	Bozeman	Montana	United States	59715
13	Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research	Bozeman	Montana	United States	59715
14	Bozeman Health Deaconess Hospital	Bozeman	Montana	United States	59715
15	Mary Crowley Cancer Research	Dallas	Texas	United States	75230
16	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
17	US Oncology Investigational Product Center (IPC)	Irving	Texas	United States	75063
18	Texas Oncology - Longview Cancer Center	Longview	Texas	United States	75601
19	Texas Oncology-Paris	Paris	Texas	United States	75460
20	Texas Oncology- Tyler	Tyler	Texas	United States	75702
21	Cancer Center IDS Pharmacy	Charlottesville	Virginia	United States	22903
22	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22903
23	UVA Health System; Attention: GI Team	Charlottesville	Virginia	United States	22903
24	University of Virginia Health System	Charlottesville	Virginia	United States	22908
25	MultiCare Regional Cancer Center - Auburn	Auburn	Washington	United States	98001
26	MultiCare Regional Cancer Center - Gig Harbor Medical Park	Gig Harbor	Washington	United States	98335
27	MultiCare Regional Cancer Center - Puyallup	Puyallup	Washington	United States	98372
28	Medical Oncology Associates, PS (dba Summit Cancer Centers)	Spokane Valley	Washington	United States	99216
29	MultiCare Institute for Research & Innovation	Tacoma	Washington	United States	98405
30	MultiCare Regional Cancer Center - Tacoma	Tacoma	Washington	United States	98405
31	Wenatchee Valley Hospital	Wenatchee	Washington	United States	98801
32	The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6