Trial · NCT04803305
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
NCT04803305, Phase 1, Completed, Pfizer; results first posted 2024-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia. Trials, record NCT04803305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04803305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
- NCT number
- NCT04803305
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer, Breast Cancer, Ovarian Cancer, Loss of Appetite, Fatigue, Cachexia, Anorexia
- Interventions
- PF-06946860, Placebo for PF-06946860
- First posted
- 2021-03-17
- Last updated
- 2024-01-12
- Results first posted
- 2024-01-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | 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. |
| Secondary | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 5 and 6 | 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. |
| Secondary | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 4, 5 and 6 | 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. |
| Secondary | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Day 1 through Week 6 (for a period of 6 weeks) | 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. |
| Secondary | Number of Participants With Laboratory Test Abnormalities in Part A | Days 1, 22 and 43 | 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 \[/low power field (LPF)\]). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | Baseline, Week 4 | The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed/number analyzed = number of participants evaluable for this OM in each treatment group. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 5 and 6 | The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A | Baseline, Weeks 1, 2, 3, 4, 5 and 6 | The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A | Day 1 through Week 6 (for a period of 6 weeks) | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities in Part A | Days 1, 22 and 43 | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | Placebo | 2.45 | 90% Confidence Interval 1.01 to 3.88 | Units on a Scale | |
| Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A | PF-06946860 200mg Q3W | 1.84 | 90% Confidence Interval 0.79 to 2.90 | 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 | Placebo | Week 1 | 0.99 | 90% Confidence Interval -0.66 to 2.64 | 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 | PF-06946860 200mg Q3W | Week 1 | 2.19 | 90% Confidence Interval 1.17 to 3.20 | 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 | Placebo | Week 2 | 1.11 | 90% Confidence Interval -0.03 to 2.25 | 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 | PF-06946860 200mg Q3W | Week 2 | 2.21 | 90% Confidence Interval 1.45 to 2.98 | 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 | Placebo | Week 3 | 1.27 | 90% Confidence Interval -0.35 to 2.89 | 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 | PF-06946860 200mg Q3W | Week 3 | 2.30 | 90% Confidence Interval 1.20 to 3.41 | 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 | Placebo | Week 5 | 1.95 | 90% Confidence Interval 0.27 to 3.63 | 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 | PF-06946860 200mg Q3W | Week 5 | 1.95 | 90% Confidence Interval 0.82 to 3.08 | Units on a Scale |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: 6-week Double-blind Treatment | STARTED | Placebo -> OL PF-06946860 200mg Q3W | 6 | |
| Part A: 6-week Double-blind Treatment | STARTED | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 12 | |
| Part A: 6-week Double-blind Treatment | COMPLETED | Placebo -> OL PF-06946860 200mg Q3W | 5 | |
| Part A: 6-week Double-blind Treatment | COMPLETED | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 9 | |
| Part A: 6-week Double-blind Treatment | NOT COMPLETED | Placebo -> OL PF-06946860 200mg Q3W | 1 | |
| Part A: 6-week Double-blind Treatment | NOT COMPLETED | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 3 | |
| Part B: OLT Period up to 18 Weeks | STARTED | Placebo -> OL PF-06946860 200mg Q3W | 5 | |
| Part B: OLT Period up to 18 Weeks | STARTED | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 9 | |
| Part B: OLT Period up to 18 Weeks | COMPLETED | Placebo -> OL PF-06946860 200mg Q3W | 2 | |
| Part B: OLT Period up to 18 Weeks | COMPLETED | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06946860 200mg Q3W | 1 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo -> OL PF-06946860 200mg Q3W | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 1 | 12 | |
| other | Ocular hyperaemia | Eye disorders | Placebo | 0 | 6 | |
| other | Ocular hyperaemia | Eye disorders | PF-06946860 200mg Q3W | 0 | 12 | |
| other | Ocular hyperaemia | Eye disorders | Placebo -> OL PF-06946860 200mg Q3W | 1 | 6 | |
| other | Ocular hyperaemia | Eye disorders | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 0 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | PF-06946860 200mg Q3W | 0 | 12 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 6 |
| Total, all-cause mortality | PF-06946860 200mg Q3W | 2 | 12 |
| Total, all-cause mortality | Placebo -> OL PF-06946860 200mg Q3W | 2 | 6 |
| Total, all-cause mortality | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 4 | 12 |
| Total, other adverse events | Placebo | 4 | 6 |
| Total, other adverse events | PF-06946860 200mg Q3W | 4 | 12 |
| Total, other adverse events | Placebo -> OL PF-06946860 200mg Q3W | 6 | 6 |
| Total, other adverse events | PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W | 8 | 12 |
| Total, serious adverse events | Placebo | 1 | 6 |
| Total, serious adverse events | PF-06946860 200mg Q3W | 3 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04803305
GET https://conductscience.org/api/trials/v1/NCT04803305/results?page=2