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2020-11-17
2022-03-30
2022-03-30
11
NCT04299048
Pfizer
Pfizer
INTERVENTIONAL
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include: * body weight measurements * blood pressure and heart rate measurements * Lumbar Skeletal Muscle Index (LSMI) by CT scan * Blood samples: * to evaluate safety, * to measure the amount of the study drug in the blood, * to evaluate if the study drug causes an immune response, * to examine the effects of the study drug on levels of a specific cytokine, * and for exploratory samples for bio banking. * Measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires. * Measure the impact of study drug on physical activity using wearable digital sensors. * To evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia. * To evaluate tumor size.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-02-19 | 2023-03-09 | 2023-03-09 |
2020-03-04 | 2023-03-09 | 2023-12-14 |
2020-03-06 | 2023-12-14 | 2023-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: PF-06946860 subcutaneous injection | DRUG: PF-06946860
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | From Day 1 up to Week 24 |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 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. | From Day 1 up to Week 24 |
| Number of Participants With Post-Baseline Vital Signs Abnormalities | 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. | From Day 1 up to Week 24 |
| Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities | 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. | From Day 1 up to Week 24 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Serum Unbound Trough Concentrations (Ctrough) of PF-06946860 | 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. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 |
| Serum Total Ctrough of PF-06946860 | 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. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
