Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Condition: Cachexia; Non-Small-Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasms; Wasting Syndrome; Cachexia
Intervention: PF-06946860
Intervention description: subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cachexia, non-small cell lung cancer, pancreatic cancer; colorectal cancer, weight loss, anorexia, muscle loss, fatigue

Summary:

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

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