Status:
COMPLETED
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Lead Sponsor:
Pfizer
Conditions:
Cachexia
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 colorec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04299048
Start Date
November 17 2020
End Date
March 30 2022
Last Update
December 14 2023
Active Locations (10)
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1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
2
SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81501
3
Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
4
Tallahassee Memorial Healthcare Cancer Center
Tallahassee, Florida, United States, 32308