Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 14, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: PF-06946860
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Beverly Hills Cancer CenterBeverly Hills, California
- SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical CenterGrand Junction, Colorado
- Lutheran Medical CenterWheat Ridge, Colorado
- Tallahassee Memorial Healthcare Cancer CenterTallahassee, Florida
- Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana
- New England Cancer SpecialistsScarborough, Maine
- American Oncology Partners of Maryland, PABethesda, Maryland
- American Oncology Partners of Maryland, PAGermantown, Maryland
- Duke Cancer CenterDurham, North Carolina
- VA Puget Sound Health Care SystemSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 14, 2023. Always confirm current availability with the study team.