A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)

NCT02586857 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 1 other identifier: ACE-ST-209
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme; GBM; Btk,; CLL; Chronic Lymphocytic Leukemia; NK; Natural Killer (Cells); ORR; Overall Response Rate; OS; Overall Survival; RANO; Response Assessment in Neuro-oncology (Criteria); RCI; Reliale Change Index (methodology)

Outcome Measures

Primary Outcomes (1)

• Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.

  To evaluate the efficacy of acalabrutinib monotherapy in subjects with recurrent GBM based on overall response rate (ORR) per the Response Assessment in Neuro-oncology (RANO) criteria. Responses are either complete response (CR) or partial response (PR) by RANO.

  On Cycle 3 Day 1, Cycle 4 Day 1 (4 weeks after Cycle 3 Day 1 scan to evaluate for response stability), then on Day 1 of every other cycle (every 8 weeks) thereafter (e.g., Cycle 6 Day 1, Cycle 8 Day 1)

Study Arms (2)

Cohort 1

EXPERIMENTAL

ACP-196 200 mg administered orally (PO) twice per day (BID)

Drug: ACP-196

Cohort 2

EXPERIMENTAL

ACP-196 400mg administered orally (PO) once per day (QD).

Drug: ACP-196

Interventions

ACP-196 DRUG

Cohort 1: ACP-196 200 mg (PO) twice per day (BID) Cohort 2: ACP-196 400 mg (PO) once per day (QD).

Also known as: Acalabrutinib.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥18 years of age
• Histologically confirmed GBM at first or second recurrence after concurrent or adjuvant chemotherapy or radiotherapy (must have received temozolomide).
• Radiographic demonstration of disease progression by MRI following prior therapy.
• Measurable disease (bidimensional) as defined by the RANO criteria, with a minimum measurement of 1 cm in longest diameter on MRI performed within 21 days of first dose of acalabrutinib; MRI must have been obtained ≥4 weeks after any salvage surgery after first or second relapse.
• Stable or decreasing dose of corticosteroids ≥5 days before baseline MRI (at study entry).
• On a stable dose of any required therapy (such as anticonvulsant medication for subjects to be enrolled into the Phase 1b portion), for ≥3 weeks before the first dose of acalabrutinib.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Life expectancy ≥ 12 weeks.
• Completion of all prior anticancer therapy before first ACP-196 dose.
• Need to have recovered (i.e., Grade ≤1 or baseline) from AEs associated with prior cancer therapy. Note: Subjects with Grade ≤2 neuropathy or Grade
• alopecia are an exception, and may qualify for the study.

You may not qualify if:

• Three or more prior lines of systemic therapy for GBM.
• Prior malignancy (other than GBM), 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. Any cases of prior malignancy allowed on study are to be approved by the study medical monitor.
• Significant cardiovascular disease.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
• Evidence of bleeding diathesis or coagulopathy.
• Requires urgent palliative intervention for primary disease
• Requires treatment with a strong CYP3A4 inhibitor..
• History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
• Breastfeeding or pregnant.
• Subjects previously treated with bevacizumab (Avastin)

Sponsors & Collaborators

• Acerta Pharma BV: lead

Study Sites (7)

Research Site

Los Angeles, California, 90095-1769, United States

Location

Research Site

Palo Alto, California, 94304, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Boston, Massachusetts, 2215, United States

Location

Research Site

New York, New York, 10021, United States

Location

Research Site

Vancouver, Washington, 98684, United States

Location

Related Links

• Redacted CSP

MeSH Terms

Conditions

Glioblastoma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2015
• First Posted: October 27, 2015
• Study Start: January 25, 2016
• Primary Completion: June 26, 2020
• Study Completion: April 1, 2026
• Last Updated: March 25, 2026
• Results First Posted: July 29, 2020

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (7)