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

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: ACP-196; Drug: ACP-196 in combination with pembrolizumab

• Registration Number: NCT02362048
• Lead Sponsor: Acerta Pharma BV

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-07
• Study First Posted: 2015-02-12
• Study Start: 2015-05
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2019-07-19
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Results First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Arm 1	ACP-196	ACP-196 alone
Experimental: Arm 2	ACP-196 in combination with pembrolizumab	ACP-196 in combination with pembrolizumab

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.	Every 12 weeks for up to 2 years.	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR