CachexiaPhase 1NCT04299048
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
A Phase 1 study testing PF-06946860 in people with Cachexia and Non-Small-Cell Lung Cancer, run by Pfizer at 10 sites in United States.
Trial summary
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer
- What is being tested?
- PF-06946860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Nov 2020to 30 Mar 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 histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
- Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
- Will receive the following for non-small cell lung cancer:
- a platinum + pemetrexed ± pembrolizumab or
- a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or
- pembrolizumab alone
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- Will receive the following for pancreatic cancer:
- FOLFIRINOX or
- Nab-Paclitaxel + Gemcitabine
- Gemcitabine
- Will receive the following for colorectal cancer:
- FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- Pembrolizumab for MSI-H • Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy.
- Adequate renal and liver function.
- Signed informed consent.
Who cannot join
- All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence).
- Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted
- Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS.
- known symptomatic brain metastases requiring steroids.
- Active hepatitis B or C virus.
- Confirmed positive HIV test.
Show all 10Show fewer
- Current active reversible causes of decreased food intake.
- Receiving tube feedings or parenteral nutrition at Screening.
- Elevated blood pressure that cannot be controlled by medications.
- Women who are pregnant or breast-feeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Duke Cancer Center
Durham, North Carolina, 27710
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
American Oncology Partners of Maryland, PA
Germantown, Maryland, 20874
SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
New England Cancer Specialists
Scarborough, Maine, 04074
VA Puget Sound Health Care System
Seattle, Washington, 98108
Tallahassee Memorial Healthcare Cancer Center
Tallahassee, Florida, 32308
Lutheran Medical Center
Wheat Ridge, Colorado, 80033
About this study
Official title: A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 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.
Read the detailed description
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.
- Being tested
- PF-06946860
- Keywords
- cachexia, non-small cell lung cancer, pancreatic cancer, colorectal cancer, weight loss, anorexia, muscle loss, fatigue
- Medical subject headings
- Cachexia, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms, Weight Loss, Anorexia, Muscular Atrophy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06946860Drug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| PF-06946860 | Experimental | subcutaneous injection Receives: Drug: PF-06946860 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 up to Week 24
Secondary outcomes (2)
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.
Measured: 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.
Measured: Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start17 Nov 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 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 CachexiaStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT04299048
- Sponsor's protocol ID
- C3651009
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2020
- Last updated
- 14 Dec 2023
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA
- ClinicalTrials.gov ID
- NCT04299048
- Acronym / sponsor ID
- C3651009
- Keywords
- cachexia, non-small cell lung cancer, pancreatic cancer, colorectal cancer, weight loss, anorexia, muscle loss, fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-06946860 | Experimental | Drug: 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 (17 listed)
- Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
- Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
- Will receive the following for non-small cell lung cancer:
- Will receive the following for pancreatic cancer:
- Will receive the following for colorectal cancer:
Key exclusion criteria (10 listed)
- All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence).
- Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted
- Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS.
- known symptomatic brain metastases requiring steroids.
- Active hepatitis B or C virus.
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 | PF-06946860 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: 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.
Number of Participants With Post-Baseline Vital Signs Abnormalities
Time frame: 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.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Time frame: 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.
2 secondary outcomes
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Time frame: Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
Serum Total Ctrough of PF-06946860
Time frame: Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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
10 sites in 1 country: 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 Cachexia and Non-Small-Cell Lung Cancer, run by Pfizer at 10 sites in United States.
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 17 inclusion and 10 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 14 Dec 2023). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From Day 1 up to Week 24). The study lists 4 primary outcomes in all. 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 14 Dec 2023.