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)
40
Enrollment
32
Locations
2
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.

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

ArmIntervention/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

  1. 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

  1. 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.

  2. 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.

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Week 6]

    Incidence of adverse events

  4. 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:
No
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

SiteCityStateCountryPostal Code
1Carti Cancer CenterLittle RockArkansasUnited States72205
2Tower Hematology Oncology Medical Group (THO)Beverly HillsCaliforniaUnited States90211
3Ventura County Hematology- Oncology SpecialistsCamarilloCaliforniaUnited States93010
4Cedars- Sinai Medical CenterLos AngelesCaliforniaUnited States90048
5Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCaliforniaUnited States90048
6Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
7Ventura County Hematology Oncology SpecialistsOxnardCaliforniaUnited States93030
8Providence Medical FoundationSanta RosaCaliforniaUnited States95403
9Ventura County Hematology-Oncology SpecialistsVenturaCaliforniaUnited States93003
10Lutheran Medical CenterWheat RidgeColoradoUnited States80033
11Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndianaUnited States46804
12Bozeman Health Cancer CenterBozemanMontanaUnited States59715
13Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical ResearchBozemanMontanaUnited States59715
14Bozeman Health Deaconess HospitalBozemanMontanaUnited States59715
15Mary Crowley Cancer ResearchDallasTexasUnited States75230
16The University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030
17US Oncology Investigational Product Center (IPC)IrvingTexasUnited States75063
18Texas Oncology - Longview Cancer CenterLongviewTexasUnited States75601
19Texas Oncology-ParisParisTexasUnited States75460
20Texas Oncology- TylerTylerTexasUnited States75702
21Cancer Center IDS PharmacyCharlottesvilleVirginiaUnited States22903
22University of Virginia Cancer CenterCharlottesvilleVirginiaUnited States22903
23UVA Health System; Attention: GI TeamCharlottesvilleVirginiaUnited States22903
24University of Virginia Health SystemCharlottesvilleVirginiaUnited States22908
25MultiCare Regional Cancer Center - AuburnAuburnWashingtonUnited States98001
26MultiCare Regional Cancer Center - Gig Harbor Medical ParkGig HarborWashingtonUnited States98335
27MultiCare Regional Cancer Center - PuyallupPuyallupWashingtonUnited States98372
28Medical Oncology Associates, PS (dba Summit Cancer Centers)Spokane ValleyWashingtonUnited States99216
29MultiCare Institute for Research & InnovationTacomaWashingtonUnited States98405
30MultiCare Regional Cancer Center - TacomaTacomaWashingtonUnited States98405
31Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801
32The Ottawa Hospital Cancer CentreOttawaOntarioCanadaK1H 8L6

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04803305
Other Study ID Numbers:
  • C3651010
First Posted:
Mar 17, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022