Safety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia

NCT04299048

Last updated date
Study Location
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cachexia, Non-Small-Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Documented diagnosis of stage III or advanced metastatic stage IV NSCLC.

- 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 platinum-based therapy with a platin + pemetrexed ± pembrolizumab or platin + nab paclitaxel

± pembrolizumab as first or second line therapy; and at the first cycle of platinum based therapy.

- Adequate renal and liver function.

- Signed informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Other forms of lung cancer


- 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.


- 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

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[email protected]

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Cachexia, Non-Small-Cell Lung CancerSafety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia
NCT04299048
  1. Beverly Hills, California
  2. Grand Junction, Colorado
  3. Fleming Island, Florida
  4. Jacksonville Beach, Florida
  5. Jacksonville, Florida
  6. Jacksonville, Florida
  7. Jacksonville, Florida
  8. Jacksonville, Florida
  9. Jacksonville, Florida
  10. Saint Augustine, Florida
  11. Tallahassee, Florida
  12. Fort Wayne, Indiana
  13. Durham, North Carolina
  14. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia
Official Title  ICMJE 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 NON-SMALL CELL LUNG CANCER AND CACHEXIA
Brief Summary 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 Cancer and cachexia feel after receiving repeated subcutaneous dosing.
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 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 mass and 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 NSCLC and cachexia.
  • To evaluate tumor size.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cachexia
  • Non-Small-Cell Lung Cancer
Intervention  ICMJE Drug: PF-06946860
subcutaneous injection
Study Arms  ICMJE Experimental: subcutaneous injection
Intervention: Drug: PF-06946860
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2021
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of stage III or advanced metastatic stage IV NSCLC.
  • 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 platinum-based therapy with a platin + pemetrexed ± pembrolizumab or platin + nab paclitaxel

    ± pembrolizumab as first or second line therapy; and at the first cycle of platinum based therapy.

  • Adequate renal and liver function.
  • Signed informed consent.

Exclusion Criteria:

  • Other forms of lung cancer
  • 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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04299048
Other Study ID Numbers  ICMJE C3651009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP