Expired Study
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Houston, Texas


Purpose:

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


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


Study is Available At:


Original ID:

ACE-ST-003


NCT ID:

NCT02362048


Secondary ID:


Study Acronym:

KEYNOTE144


Brief Title:

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


Official Title:

A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Acerta Pharma BV


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

77


Enrollment Type:

Actual


Overall Contact Information

Official Name:Acerta Clinical Trial
Study Director
1-888-292-9613; acertamc@dlss.com

Study Dates

Start Date:May 2015
Completion Date:March 2017
Completion Type:Actual
Primary Completion Date:March 2017
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 12, 2019
First Received Date:January 28, 2015
First Results Date:July 19, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
Time Frame:Every 12 weeks for up to 2 years.
Safety Issues:False
Description: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 tar

Study Interventions

Intervention Type:Drug
Name:ACP-196
Arm Name:Experimental: Arm 1
Intervention Type:Drug
Name:ACP-196 in combination with pembrolizumab
Arm Name:Experimental: Arm 2

Study Arms

Study Arm Type:Experimental
Arm Name:Experimental: Arm 1
Description:ACP-196 alone
Study Arm Type:Experimental
Arm Name:Experimental: Arm 2
Description:ACP-196 in combination with pembrolizumab

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Acerta Pharma BV
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck Sharp & Dohme Corp.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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