Non-small Cell Lung CancerPhase 1NCT04803305
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 study testing PF-06946860 in people with Non-small Cell Lung Cancer and Pancreatic Cancer, run by Pfizer at 33 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- What is being tested?
- PF-06946860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 11 May 2021to 9 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States32 sites
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, 98001
Tower Hematology Oncology Medical Group (THO)
Beverly Hills, California, 90211
Bozeman Health Cancer Center
Bozeman, Montana, 59715
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
Bozeman, Montana, 59715
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Ventura County Hematology- Oncology Specialists
Camarillo, California, 93010
Cancer Center IDS Pharmacy
Charlottesville, Virginia, 22903
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
UVA Health System; Attention: GI Team
Charlottesville, Virginia, 22903
University of Virginia Health System
Charlottesville, Virginia, 22908
Mary Crowley Cancer Research
Dallas, Texas, 75230
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
MultiCare Regional Cancer Center - Gig Harbor Medical Park
Gig Harbor, Washington, 98335
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
CARTI Cancer Center
Little Rock, Arkansas, 72205
Texas Oncology - Longview Cancer Center
Longview, Texas, 75601
Cedars- Sinai Medical Center
Los Angeles, California, 90048
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Moses Lake Clinic
Moses Lake, Washington, 98837
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
Texas Oncology-Paris
Paris, Texas, 75460
MultiCare Regional Cancer Center - Puyallup
Puyallup, Washington, 98372
Providence Medical Foundation
Santa Rosa, California, 95403
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane Valley, Washington, 99216
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, 98405
Texas Oncology- Tyler
Tyler, Texas, 75702
Ventura County Hematology-Oncology Specialists
Ventura, California, 93003
Wenatchee Valley Hospital
Wenatchee, Washington, 98801
Lutheran Medical Center
Wheat Ridge, Colorado, 80033
About this study
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 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.
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer, Breast Cancer, Ovarian Cancer
- Being tested
- PF-06946860, Placebo for PF-06946860
- Keywords
- cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Anorexia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06946860Drug
subcutaneous injection
Placebo for PF-06946860Drug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment | Experimental | subcutaneous injection Receives: Drug: PF-06946860 |
| Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment | Placebo comparator | subcutaneous injection Receives: Drug: PF-06946860; Drug: Placebo for PF-06946860 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4
Secondary outcomes (4)
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.
Measured: Baseline, Weeks 1, 2, 3, 5 and 6
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.
Measured: Baseline, Weeks 1, 2, 3, 4, 5 and 6
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.
Measured: Day 1 through Week 6 (for a period of 6 weeks)
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)]).
Measured: Days 1, 22 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start11 May 2021
- Primary completion14 Apr 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803305
- Sponsor's protocol ID
- C3651010
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2021
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04803305
- Acronym / sponsor ID
- C3651010
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer, Breast Cancer, Ovarian Cancer
- Keywords
- cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment | Experimental | Drug: PF-06946860subcutaneous injection |
| Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment | Placebo comparator | Drug: PF-06946860, Drug: Placebo for PF-06946860subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Signed informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06946860subcutaneous injection | Drug | Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment, Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment |
| Placebo for PF-06946860subcutaneous injection | Drug | Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment |
Primary outcome
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
Time frame: Baseline, Week 4
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.
4 secondary outcomes
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
Time frame: Baseline, Weeks 1, 2, 3, 5 and 6
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
Time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
Time frame: Day 1 through Week 6 (for a period of 6 weeks)
Number of Participants With Laboratory Test Abnormalities in Part A
Time frame: Days 1, 22 and 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06946860 in people with Non-small Cell Lung Cancer and Pancreatic Cancer, run by Pfizer at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.