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Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.

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ClinicalTrials.gov Identifier: NCT04299048
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.

Condition or disease Intervention/treatment Phase
Cachexia Non-Small-Cell Lung Cancer Pancreatic Cancer Colorectal Cancer Drug: PF-06946860 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : June 5, 2022
Estimated Study Completion Date : June 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06946860
subcutaneous injection
Drug: PF-06946860
subcutaneous injection




Primary Outcome Measures :
  1. safety and tolerability of repeated study drug administrations [ Time Frame: 24 weeks ]
    Incidence of treatment emergent adverse events (AEs and SAEs), safety laboratory tests, vital signs and standard ECG parameters.


Secondary Outcome Measures :
  1. Serum unbound concentration [ Time Frame: Weeks 3, 6, 9, 12, and 15 ]
  2. total trough concentrations (Ctrough) [ Time Frame: Weeks 3, 6, 9, 12, and 15 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299048


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Beverly Hills Cancer Center Recruiting
Beverly Hills, California, United States, 90211
United States, Colorado
SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center Recruiting
Grand Junction, Colorado, United States, 81501
Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Cancer Specialists of North Florida Not yet recruiting
Fleming Island, Florida, United States, 32003
Cancer Specialists of North Florida Not yet recruiting
Jacksonville Beach, Florida, United States, 32250
Cancer Specialists of North Florida Not yet recruiting
Jacksonville, Florida, United States, 32204
Cancer Specialists of North Florida Not yet recruiting
Jacksonville, Florida, United States, 32207
Cancer Specialists of North Florida Not yet recruiting
Jacksonville, Florida, United States, 32256
Cancer Specialists of North Florida Not yet recruiting
Jacksonville, Florida, United States, 32258
Cancer Specialists of North Florida Not yet recruiting
Saint Augustine, Florida, United States, 32086
Tallahassee Memorial Healthcare Cancer Center Recruiting
Tallahassee, Florida, United States, 32308
United States, Illinois
Rush University Medical Center Professional Office Building Infusion Pharmacy Not yet recruiting
Chicago, Illinois, United States, 60612
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc. Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
American Oncology Partners of Maryland, PA Recruiting
Bethesda, Maryland, United States, 20817
American Oncology Partners of Maryland, PA Recruiting
Germantown, Maryland, United States, 20874
United States, Michigan
St. Joseph Mercy Hospital Not yet recruiting
Ann Arbor, Michigan, United States, 48106
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04299048    
Other Study ID Numbers: C3651009
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
cachexia, non-small cell lung cancer, pancreatic cancer
colorectal cancer, weight loss, anorexia, muscle loss, fatigue
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Wasting Syndrome
Cachexia
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases