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
Recruiting
CT.gov ID
NCT04803305
Collaborator
(none)
40
Enrollment
56
Locations
2
Arms
12.9
Anticipated Duration (Months)
0.7
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 DiseaseIntervention/TreatmentPhase
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:
Parallel 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 :
May 12, 2022
Anticipated Study Completion Date :
Jun 8, 2022

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
3Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbankCaliforniaUnited States91505
4Providence Saint Joseph Medical CenterBurbankCaliforniaUnited States91505
5Ventura County Hematology- Oncology SpecialistsCamarilloCaliforniaUnited States93010
6Pacific Shores Medical GroupHuntington BeachCaliforniaUnited States92648
7Pacific Shores Medical GroupIrvineCaliforniaUnited States92618
8Pacific Shores Medical GroupLong BeachCaliforniaUnited States90808
9Pacific Shores Medical GroupLong BeachCaliforniaUnited States90813
10Cedars- Sinai Medical CenterLos AngelesCaliforniaUnited States90048
11Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCaliforniaUnited States90048
12Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
13Pacific Shores Medical GroupNewport BeachCaliforniaUnited States92663
14Ventura County Hematology Oncology SpecialistsOxnardCaliforniaUnited States93030
15Providence Medical FoundationSanta RosaCaliforniaUnited States95403
16Pacific Shores Medical GroupTorranceCaliforniaUnited States90505
17Ventura County Hematology-Oncology SpecialistsVenturaCaliforniaUnited States93003
18Lutheran Medical CenterWheat RidgeColoradoUnited States80033
19Danbury HospitalDanburyConnecticutUnited States06810
20Norwalk HospitalNorwalkConnecticutUnited States06856
21Rush University Medical Center Professional Office Building Infusion PharmacyChicagoIllinoisUnited States60612
22Rush University Medical CenterChicagoIllinoisUnited States60612
23Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndianaUnited States46804
24Bozeman Health Cancer CenterBozemanMontanaUnited States59715
25Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical ResearchBozemanMontanaUnited States59715
26Bozeman Health Deaconess HospitalBozemanMontanaUnited States59715
27New York Oncology Hematology PCAlbanyNew YorkUnited States12206
28New York Oncology Hematology, PCAlbanyNew YorkUnited States12208
29New York Oncology Hematology PCClifton ParkNew YorkUnited States12065
30The Lindner Center for Research and Education at The Christ HospitalCincinnatiOhioUnited States45219
31The Christ Hospital Medical Specialists II Hematology OncologyCincinnatiOhioUnited States45227
32The Christ Hospital Medical Specialists II Hematology OncologyCincinnatiOhioUnited States45248
33The Christ Hospital Medical Specialists II Hematology OncologyCincinnatiOhioUnited States45249
34Texas Oncology - Austin MidtownAustinTexasUnited States78705
35Texas Oncology - Austin CentralAustinTexasUnited States78731
36Texas Oncology - South AustinAustinTexasUnited States78745
37Mary Crowley Cancer ResearchDallasTexasUnited States75230
38The University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030
39US Oncology Investigational Product Center (IPC)IrvingTexasUnited States75063
40Texas Oncology - Longview Cancer CenterLongviewTexasUnited States75601
41Texas Oncology-New BraunfelsNew BraunfelsTexasUnited States78130
42Texas Oncology-ParisParisTexasUnited States75460
43Texas Oncology-San Antonio DowntownSan AntonioTexasUnited States78212
44Texas Oncology-San Antonio NortheastSan AntonioTexasUnited States78217
45Texas Oncology - San AntonioSan AntonioTexasUnited States78240
46Texas Oncology-San Antonio Stone OakSan AntonioTexasUnited States78258
47Texas Oncology- TylerTylerTexasUnited States75702
48MultiCare Regional Cancer Center - AuburnAuburnWashingtonUnited States98001
49MultiCare Regional Cancer Center - Gig Harbor Medical ParkGig HarborWashingtonUnited States98335
50MultiCare Regional Cancer Center - PuyallupPuyallupWashingtonUnited States98372
51Medical Oncology Associates, PS (dba Summit Cancer Centers)Spokane ValleyWashingtonUnited States99216
52MultiCare Institute for Research & InnovationTacomaWashingtonUnited States98405
53MultiCare Regional Cancer Center - TacomaTacomaWashingtonUnited States98405
54Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801
55Jewish General HospitalMontrealQuebecCanadaH3T 1E2
56CISSSBSLRimouskiQuebecCanadaG5L 5T1

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:
Nov 19, 2021
Last Verified:
Nov 1, 2021
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
cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
Additional relevant MeSH terms:
Wasting Syndrome
Fatigue
Anorexia
Cachexia

Study Results

No Results Posted as of Nov 19, 2021