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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Arm 1

ACP-196 alone

Group Type EXPERIMENTAL

ACP-196

Intervention Type DRUG

Experimental: Arm 2

ACP-196 in combination with pembrolizumab

Group Type EXPERIMENTAL

ACP-196 in combination with pembrolizumab

Intervention Type DRUG

Interventions

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ACP-196

Intervention Type DRUG

ACP-196 in combination with pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No