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

Completed · Phase 1

Conditions studied: Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer

In brief

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

Key facts

Study ID

NCT04299048

Run by

Pfizer

People needed

11

Starts

2020-11-17

Expected to finish

2022-03-30

Last updated by the study team

2023-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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