Study to Determine the Safety of the Study Drug, How it 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 (SC-injected Under the Skin) Doses.

NCT04299048

Last updated date
Study Location
VA Puget Sound Health Care System
Seattle, Washington, 98108, 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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By email

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[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, Pancreatic Cancer, Colorectal 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 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

- 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.

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


- 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.


- 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 Cancer, Pancreatic Cancer, Colorectal CancerStudy to Determine the Safety of the Study Drug, How it 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 (SC-injected Under the Skin) Doses.
NCT04299048
  1. Seattle, Washington
  2. Beverly Hills, California
  3. Grand Junction, Colorado
  4. Wheat Ridge, Colorado
  5. Fleming Island, Florida
  6. Jacksonville Beach, Florida
  7. Jacksonville, Florida
  8. Jacksonville, Florida
  9. Jacksonville, Florida
  10. Jacksonville, Florida
  11. Saint Augustine, Florida
  12. Tallahassee, Florida
  13. Chicago, Illinois
  14. Chicago, Illinois
  15. Fort Wayne, Indiana
  16. Scarborough, Maine
  17. Bethesda, Maryland
  18. Germantown, Maryland
  19. Ann Arbor, Michigan
  20. Brighton, Michigan
  21. Ypsilanti, Michigan
  22. Durham, North Carolina
  23. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Determine the Safety of the Study Drug, How it 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 (SC-injected Under the Skin) Doses.
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 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 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, 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 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
  • Pancreatic Cancer
  • Colorectal Cancer
Intervention  ICMJE Drug: PF-06946860
subcutaneous injection
Study Arms  ICMJE Experimental: PF-06946860
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 January 24, 2022
Estimated Primary Completion Date January 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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 March 2021

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