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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.

NCT04299048

CompletedPhase 1

Sponsor: Pfizer

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

Interventions: PF-06946860

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (10)

Beverly Hills, California, United States
Grand Junction, Colorado, United States
Wheat Ridge, Colorado, United States
Tallahassee, Florida, United States
Fort Wayne, Indiana, United States
Scarborough, Maine, United States
Bethesda, Maryland, United States
Germantown, Maryland, United States
Durham, North Carolina, United States
Seattle, Washington, United States