Phase 1 N=11 Treatment

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

Cachexia · Non-Small-Cell Lung Cancer · Pancreatic Cancer · Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04299048 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Dec 2023

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 10; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-06946860 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	10; 4	—
PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	2; 2; 2; 1; 2; 3	—
PRIMARY Number of Participants With Post-Baseline Vital Signs Abnormalities	0; 2; 0; 0; 1; 0	—
PRIMARY Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Serum Unbound Trough Concentrations (Ctrough) of PF-06946860	4.041; 1690; 610.9; 4383; 560.5	—
SECONDARY Serum Total Ctrough of PF-06946860	10050; 17010; 20740; 21310; 25450	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04299048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.