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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02362048
Other study ID # ACE-ST-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2015
Est. completion date March 2017

Study information

Verified date September 2019
Source Acerta Pharma BV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
ACP-196

ACP-196 in combination with pembrolizumab


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Acerta Pharma BV Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer. 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 Every 12 weeks for up to 2 years.
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