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CompletedNCT04803305Updated Jan 12, 2024Results posted

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

A Phase 1 interventional study of PF-06946860 and Placebo for PF-06946860 in Non-small Cell Lung Cancer, Pancreatic Cancer and Colorectal Cancer, sponsored by Pfizer. Completed at 33 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • 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
03

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

This study's enrollment of 18 is below the median of 58 across 130 interventional studies indexed under Wasting Syndrome.

Browse Wasting Syndrome studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
18 participants (actual)

Study arms

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

    subcutaneous injection

    Drug: PF-06946860

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

    subcutaneous injection

    Drug: PF-06946860 · Drug: Placebo for PF-06946860

Interventions

  • DrugPF-06946860

    subcutaneous injection

  • DrugPlacebo for PF-06946860

    subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A

    The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.

    Time frame: Baseline, Week 4

Secondary outcomes

  1. Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A

    The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.

    Time frame: Baseline, Weeks 1, 2, 3, 5 and 6

  2. Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A

    The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.

    Time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6

  3. Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

    Time frame: Day 1 through Week 6 (for a period of 6 weeks)

  4. Number of Participants With Laboratory Test Abnormalities in Part A

    Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

    Time frame: Days 1, 22 and 43

07

Results

Posted Jan 12, 2024

Participant flow

Part A: 6-week Double-blind Treatment
Participant flow — Part A: 6-week Double-blind Treatment
MilestonePlacebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
Started612
Completed59
Not completed13
Withdrew: Death02
Withdrew: Withdrawal by subject01
Withdrew: Physician decision10
Part B: OLT Period up to 18 Weeks
Participant flow — Part B: OLT Period up to 18 Weeks
MilestonePlacebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
Started59
Completed25
Not completed34
Withdrew: Other01
Withdrew: Withdrawal by subject10
Withdrew: Physician decision01
Withdrew: Death12
Withdrew: Adverse event10

Outcome measures

PrimaryChange From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.

Time frame:
Baseline, Week 4
Reported as:
Least squares mean · Units on a Scale
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
Units on a ScalePlaceboPF-06946860 200mg Q3W
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A2.45 (1.01 to 3.88)1.84 (0.79 to 2.90)
Statistical analysis
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): -0.60 · 90% CI -2.38 to 1.18Week 4
SecondaryChange From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.

Time frame:
Baseline, Weeks 1, 2, 3, 5 and 6
Reported as:
Least squares mean · Units on a Scale
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
Units on a ScalePlaceboPF-06946860 200mg Q3W
Week 10.99 (-0.66 to 2.64)2.19 (1.17 to 3.20)
Week 21.11 (-0.03 to 2.25)2.21 (1.45 to 2.98)
Week 31.27 (-0.35 to 2.89)2.30 (1.20 to 3.41)
Week 51.95 (0.27 to 3.63)1.95 (0.82 to 3.08)
Week 62.41 (0.49 to 4.33)1.61 (0.32 to 2.90)
Statistical analysis
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 1.20 · 90% CI -0.75 to 3.15Week 1
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 1.10 · 90% CI -0.28 to 2.49Week 2
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 1.03 · 90% CI -0.93 to 2.99Week 3
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 0.00 · 90% CI -2.02 to 2.02Week 5
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): -0.80 · 90% CI -3.11 to 1.51Week 6
SecondaryChange From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A

The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.

Time frame:
Baseline, Weeks 1, 2, 3, 4, 5 and 6
Reported as:
Least squares mean · Units on a Scale
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
Units on a ScalePlaceboPF-06946860 200mg Q3W
Week 11.84 (-1.47 to 5.16)1.52 (-0.57 to 3.60)
Week 20.04 (-2.71 to 2.80)-2.12 (-3.91 to -0.34)
Week 3-1.21 (-2.33 to -0.09)-0.49 (-1.23 to 0.25)
Week 4-1.00 (-2.40 to 0.40)-0.55 (-1.57 to 0.48)
Week 5-0.92 (-2.47 to 0.63)-0.24 (-1.31 to 0.82)
Week 6-1.13 (-2.40 to 0.15)0.74 (-0.09 to 1.57)
Statistical analysis
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): -0.32 · 90% CI -4.18 to 3.53Week 1
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): -2.16 · 90% CI -5.49 to 1.16Week 2
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 0.72 · 90% CI -0.62 to 2.06Week 3
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 0.45 · 90% CI -1.29 to 2.20Week 4
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 0.68 · 90% CI -1.21 to 2.57Week 5
  • Placebo vs PF-06946860 200mg Q3W · Mean difference (final values): 1.86 · 90% CI 0.34 to 3.39Week 6
SecondaryNumber of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

Time frame:
Day 1 through Week 6 (for a period of 6 weeks)
Reported as:
Count of participants · Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
ParticipantsPlaceboPF-06946860 200mg Q3W
Participants With All-Causality TEAEs47
Participants With All-Causality SAEs13
SecondaryNumber of Participants With Laboratory Test Abnormalities in Part A

Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

Time frame:
Days 1, 22 and 43
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Test Abnormalities in Part A
ParticipantsPlaceboPF- 06946860 200mg Q3W
Hemoglobin <0.8 x lower limit of normal (LLN)24
Hematocrit <0.8 x LLN23
Erythrocytes <0.8 x LLN14
Erythrocytes Mean Corpuscular Volume <0.9 x LLN00
Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)01
Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN01
Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN00
Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN00
Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN00
Platelets <0.5 x LLN00
Platelets >1.75 x ULN01
Leukocytes <0.6 x LLN10
Leukocytes >1.5 x ULN00
Lymphocytes <0.8 x LLN26
Lymphocytes >1.2 x ULN00
Basophils >1.2 x ULN01
Eosinophils >1.2 x ULN00
Monocytes >1.2 x ULN01
Bilirubin >1.5 x ULN00
Aspartate Aminotransferase >3.0 x ULN00
Alanine Aminotransferase >3.0 x ULN00
Alkaline Phosphatase >3.0 x ULN02
Protein <0.8 x LLN10
Protein >1.2 x ULN00
Albumin <0.8 x LLN00
Albumin >1.2 x ULN00
Blood Urea Nitrogen >1.3 x ULN00
Creatinine >1.3 x ULN01
Urate >1.2 x ULN00
Sodium <0.95 x LLN00
Sodium >1.05 x ULN00
Potassium <0.9 x LLN00
Potassium >1.1 x ULN00
Chloride <0.9 x LLN00
Chloride >1.1 x ULN00
Calcium <0.9 x LLN00
Calcium >1.1 x ULN00
Bicarbonate <0.9 x LLN11
Bicarbonate >1.1 x ULN00
Glucose <0.6 x LLN00
Glucose >1.5 x ULN12
pH <4.500
pH >800
Urine Glucose >=101
Ketones >=100
Urine Protein >=120
Urine Hemoglobin >=102
Urobilinogen >=100
Urine Bilirubin >=100
Nitrite >=101
Leukocyte Esterase >=112
Urine Erythrocytes (/HPF) >=2001
Urine Leukocytes (/HPF) >=2001
Hyaline Casts (/LPF) >102

Adverse events

Collected over Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo1/6 (16.7%)1/6 (16.7%)4/6 (66.7%)
PF-06946860 200mg Q3W2/12 (16.7%)3/12 (25%)4/12 (33.3%)
Placebo -> OL PF-06946860 200mg Q3W2/6 (33.3%)2/6 (33.3%)6/6 (100%)
PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W4/12 (33.3%)5/12 (41.7%)8/12 (66.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboPF-06946860 200mg Q3WPlacebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
Cardiac arrestCardiac disorders1/60/121/60/12
Disease progressionGeneral disorders0/60/121/62/12
HypokalaemiaMetabolism and nutrition disorders1/60/121/60/12
Acute myocardial infarctionCardiac disorders0/61/120/61/12
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/61/120/61/12
Respiratory failureRespiratory, thoracic and mediastinal disorders0/61/120/61/12
Most frequent other events
Showing 10 of 37
Most frequent other events
EventPlaceboPF-06946860 200mg Q3WPlacebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
ConstipationGastrointestinal disorders0/60/122/60/12
FallInjury, poisoning and procedural complications1/60/122/60/12
Urinary tract infectionInfections and infestations1/63/121/63/12
Ocular hyperaemiaEye disorders0/60/121/60/12
Abdominal pain lowerGastrointestinal disorders0/60/121/60/12
NauseaGastrointestinal disorders0/61/121/62/12
VomitingGastrointestinal disorders0/61/120/62/12
FatigueGeneral disorders0/60/121/61/12
Gait disturbanceGeneral disorders0/60/121/60/12
OedemaGeneral disorders0/60/121/60/12

Baseline characteristics

The baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Age, Continuous
Age, Continuous(Years)Placebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3WTotal
Mean68.0 ± 7.9574.0 ± 9.1272.0 ± 8.99
Age, Customized
Age, Customized(Participants)Placebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3WTotal
<18000
18-44000
45-64224
>=6541014
Sex: Female, Male
Sex: Female, Male(Participants)Placebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3WTotal
Female257
Male4711
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3WTotal
Hispanic or Latino011
Not Hispanic or Latino51116
Unknown or Not Reported101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo -> OL PF-06946860 200mg Q3WPF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3WTotal
White31114
Black or African American303
Asian011
08

Study locations

33 sites
  • CARTI Cancer Center
    Little Rock, Arkansas 72205, United States
  • Tower Hematology Oncology Medical Group (THO)
    Beverly Hills, California 90211, United States
  • Ventura County Hematology- Oncology Specialists
    Camarillo, California 93010, United States
  • Cedars- Sinai Medical Center
    Los Angeles, California 90048, United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    Los Angeles, California 90048, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Ventura County Hematology Oncology Specialists
    Oxnard, California 93030, United States
  • Providence Medical Foundation
    Santa Rosa, California 95403, United States
  • Ventura County Hematology-Oncology Specialists
    Ventura, California 93003, United States
  • Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Fort Wayne Medical Oncology and Hematology, Inc.
    Fort Wayne, Indiana 46804, United States
  • Bozeman Health Cancer Center
    Bozeman, Montana 59715, United States
  • Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
    Bozeman, Montana 59715, United States
  • Bozeman Health Deaconess Hospital
    Bozeman, Montana 59715, United States
  • Mary Crowley Cancer Research
    Dallas, Texas 75230, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • US Oncology Investigational Product Center (IPC)
    Irving, Texas 75063, United States
  • Texas Oncology - Longview Cancer Center
    Longview, Texas 75601, United States
  • Texas Oncology-Paris
    Paris, Texas 75460, United States
  • Texas Oncology- Tyler
    Tyler, Texas 75702, United States
  • Cancer Center IDS Pharmacy
    Charlottesville, Virginia 22903, United States
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22903, United States
  • UVA Health System; Attention: GI Team
    Charlottesville, Virginia 22903, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
  • MultiCare Regional Cancer Center - Auburn
    Auburn, Washington 98001, United States
  • MultiCare Regional Cancer Center - Gig Harbor Medical Park
    Gig Harbor, Washington 98335, United States
  • Moses Lake Clinic
    Moses Lake, Washington 98837, United States
  • MultiCare Regional Cancer Center - Puyallup
    Puyallup, Washington 98372, United States
  • Medical Oncology Associates, PS (dba Summit Cancer Centers)
    Spokane Valley, Washington 99216, United States
  • MultiCare Institute for Research & Innovation
    Tacoma, Washington 98405, United States
  • MultiCare Regional Cancer Center - Tacoma
    Tacoma, Washington 98405, United States
  • Wenatchee Valley Hospital
    Wenatchee, Washington 98801, United States
  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario K1H 8L6, Canada
09

References and documents

Study documents

  • Study protocol · Oct 8, 2021
  • Statistical analysis plan · Apr 13, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04803305
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
May 11, 2021
Primary completion
Apr 14, 2022
Completion
Aug 9, 2022
Results posted
Jan 12, 2024
Last update
Jan 12, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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