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

• Status: Active, not recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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