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

NCT ID: NCT04299048

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2022-03-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PF-06946860

subcutaneous injection

Group Type: EXPERIMENTAL

PF-06946860

Intervention Type: DRUG

subcutaneous injection

Interventions

PF-06946860

subcutaneous injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Beverly Hills Cancer Center

Beverly Hills, California, United States

SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Lutheran Medical Center

Wheat Ridge, Colorado, United States

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

New England Cancer Specialists

Scarborough, Maine, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

American Oncology Partners of Maryland, PA

Germantown, Maryland, United States

Duke Cancer Center

Durham, North Carolina, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3651009

To obtain contact information for a study center near you, click here.

Other Identifiers

C3651009

Identifier Type: -

Identifier Source: org_study_id