NCT02537444

Brief Summary

To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

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

August 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 12, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

August 28, 2015

Results QC Date

August 5, 2019

Last Update Submit

September 12, 2019

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Overall Response

    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)

Regimen 1

EXPERIMENTAL

Drug: acalabrutinib monotherapy

Drug: Acalabrutinib

Regimen 2

EXPERIMENTAL

Drug: Combination of acalabrutinib and pembrolizumab

Drug: acalabrutinib and pembrolizumab combination

Interventions

AcalabrutinibDRUG
Also known as: ACP-196
Regimen 1
acalabrutinib and pembrolizumab combinationDRUG
Regimen 2

Eligibility Criteria

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

You may qualify if:

  • Women ≥ 18 years of age.
  • Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
  • Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
  • Platinum-sensitive ovarian cancer defined by recurrence or progression of disease \> 6 AND \< 24 months after completion of the most recent platinum-based therapy.
  • Measurable disease as defined by RECIST 1.1.
  • ECOG performance status of 0 or 1.
  • Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered.

You may not qualify if:

  • Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or \< 6 months after the beginning of first-line platinum based chemotherapy.
  • Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy.
  • More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
  • Prior malignancy (other than ovarian 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.
  • Breastfeeding and pregnant.
  • Known central nervous system metastases and/or carcinomatous meningitis.
  • Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months..
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arizona Gynecology Oncology

Tucson, Arizona, United States

Location

Jordan Center For Gynecologic Cancer At Penn

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

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 Trials

    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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 1, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

September 25, 2019

Results First Posted

September 12, 2019

Record last verified: 2019-09

Locations

US(2)