Phase 2 N=77 Randomized Treatment

ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

Metastatic Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02362048 ↗

Enrolled (actual)

Serious AEs

54.8%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer. — 0; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ACP-196 (Drug); ACP-196 in combination with pembrolizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Acerta Pharma BV
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.	0; 3	—

Summary

ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

Men and women ≥ 18 years of age
ECOG performance status of 0 or 1
Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy

Exclusion Criteria

Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction
Breastfeeding or pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02362048). 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.