NCT02362048

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

January 28, 2015

Results QC Date

July 19, 2019

Last Update Submit

September 12, 2019

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Experimental: Arm 1

EXPERIMENTAL

ACP-196 alone

Drug: ACP-196

Experimental: Arm 2

EXPERIMENTAL

ACP-196 in combination with pembrolizumab

Drug: ACP-196 in combination with pembrolizumab

Interventions

ACP-196DRUG
Experimental: Arm 1
ACP-196 in combination with pembrolizumabDRUG
Experimental: Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

Related Publications (1)

  • Overman M, Javle M, Davis RE, Vats P, Kumar-Sinha C, Xiao L, Mettu NB, Parra ER, Benson AB, Lopez CD, Munugalavadla V, Patel P, Tao L, Neelapu S, Maitra A. Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer. J Immunother Cancer. 2020 Feb;8(1):e000587. doi: 10.1136/jitc-2020-000587.

    PMID: 32114502DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

acalabrutinibpembrolizumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Priti Patel, MD, Executive Director - Head of Clinical Development
Organization
Acerta Pharma, LLC
acertamc@dlss.com
1-888-292-9613

Study Officials

  • Acerta Clinical Trial

    1-888-292-9613; acertamc@dlss.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 12, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 1, 2019

Results First Posted

October 1, 2019

Record last verified: 2019-09

Locations

US(1)