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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.

Primary Purpose

Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06946860
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia focused on measuring cachexia, non-small cell lung cancer, pancreatic cancer, colorectal cancer, weight loss, anorexia, muscle loss, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beverly Hills Cancer Center
  • SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center
  • Lutheran Medical Center
  • Tallahassee Memorial Healthcare Cancer Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • New England Cancer Specialists
  • American Oncology Partners of Maryland, PA
  • American Oncology Partners of Maryland, PA
  • Duke Cancer Center
  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PF-06946860

Arm Description

subcutaneous injection

Outcomes

Primary Outcome Measures

safety and tolerability of repeated study drug administrations
Incidence of treatment emergent adverse events (AEs and SAEs), safety laboratory tests, vital signs and standard ECG parameters.

Secondary Outcome Measures

Serum unbound concentration
total trough concentrations (Ctrough)

Full Information

First Posted
February 19, 2020
Last Updated
July 7, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04299048
Brief Title
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
Keywords
cachexia, non-small cell lung cancer, pancreatic cancer, colorectal cancer, weight loss, anorexia, muscle loss, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06946860
Arm Type
Experimental
Arm Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
PF-06946860
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
safety and tolerability of repeated study drug administrations
Description
Incidence of treatment emergent adverse events (AEs and SAEs), safety laboratory tests, vital signs and standard ECG parameters.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Serum unbound concentration
Time Frame
Weeks 3, 6, 9, 12, and 15
Title
total trough concentrations (Ctrough)
Time Frame
Weeks 3, 6, 9, 12, and 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Tallahassee Memorial Healthcare Cancer Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
American Oncology Partners of Maryland, PA
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20874
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3651009
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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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