Trial · NCT04299048
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
NCT04299048, Phase 1, Completed, Pfizer; results first posted 2023-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. Trials, record NCT04299048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04299048
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
- NCT number
- NCT04299048
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Interventions
- PF-06946860
- First posted
- 2020-03-06
- Last updated
- 2023-12-14
- Results first posted
- 2023-12-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Day 1 up to Week 24 | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. |
| Primary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | From Day 1 up to Week 24 | Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF. |
| Primary | Number of Participants With Post-Baseline Vital Signs Abnormalities | From Day 1 up to Week 24 | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm. |
| Primary | Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities | From Day 1 up to Week 24 | ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec. |
| Secondary | Serum Unbound Trough Concentrations (Ctrough) of PF-06946860 | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group. |
| Secondary | Serum Total Ctrough of PF-06946860 | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Day 1 up to Week 24 | The safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | From Day 1 up to Week 24 | Overall number of participants analyzed included participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post-Baseline Vital Signs Abnormalities | From Day 1 up to Week 24 | Overall number of participants analyzed included participants evaluated against pre-defined criteria for vital signs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities | From Day 1 up to Week 24 | Overall number of participants analyzed included participants evaluated against pre-defined criteria for ECGs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Unbound Trough Concentrations (Ctrough) of PF-06946860 | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 | The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Serum Total Ctrough of PF-06946860 | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 | The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported. | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PF-06946860 Q3W | AEs | 10 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PF-06946860 Q3W | SAEs | 4 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Hemoglobin (g/dL)< 0.8x LLN | 2 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Hematocrit (%)< 0.8x LLN | 2 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Erythrocytes (10^6/mm^3)< 0.8x LLN | 2 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Ery. Mean Corpuscular Volume (um^3)< 0.9x LLN | 1 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Leukocytes (10^3/mm^3)< 0.6x LLN | 2 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Lymphocytes (10^3/mm^3)< 0.8x LLN | 3 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Bilirubin (mg/dL)> 1.5x ULN | 1 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06946860 Q3W | Aspartate Aminotransferase (U/L)> 3.0x ULN | 1 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-06946860 Q3W | 11 | |
| Overall Study | Treated | PF-06946860 Q3W | 10 | |
| Overall Study | COMPLETED | PF-06946860 Q3W | 7 | |
| Overall Study | NOT COMPLETED | PF-06946860 Q3W | 4 |
Source ClinicalTrials.gov
Adverse events68
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 | PF-06946860 Q3W | 5 | 10 | |
| other | Monocytosis | Blood and lymphatic system disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Sinus tachycardia | Cardiac disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Hypothyroidism | Endocrine disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Conjunctival hyperaemia | Eye disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Lacrimation increased | Eye disorders | PF-06946860 Q3W | 2 | 10 | |
| other | Abdominal discomfort | Gastrointestinal disorders | PF-06946860 Q3W | 1 | 10 | |
| other | Abdominal distension | Gastrointestinal disorders | PF-06946860 Q3W | 1 | 10 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06946860 Q3W | 1 | 10 |
| Total, other adverse events | PF-06946860 Q3W | 10 | 10 |
| Total, serious adverse events | PF-06946860 Q3W | 4 | 10 |
Source ClinicalTrials.gov
Papers0
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/NCT04299048
GET https://conductscience.org/api/trials/v1/NCT04299048/results?page=2