Study on ACP-196 for Treating Recurrent Glioblastoma Multiforme (GBM)

Sponsor: Acerta Pharma BV

Sponsor score: 0

ClinicalTrials ID:NCT02586857

This clinical trial is testing the safety and effectiveness of a new drug, ACP-196, for patients with glioblastoma multiforme (GBM) that has returned after previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug ACP-196 works and how safe it is for patients with glioblastoma multiforme (GBM) that has come back after one or two previous treatments. The study is open to adults who have shown disease progression after prior therapies and meet specific health criteria.

Description

This study is designed to test a new treatment called ACP-196 for patients with glioblastoma multiforme (GBM) that has returned after previous treatments. The study will take place at multiple centers and will be open-label, meaning both the researchers and participants know what treatment is being given. The main goals are to see if ACP-196 can help control the cancer and to monitor any side effects. Participants will need to have had their GBM confirmed by a doctor and show that the cancer has progressed after previous treatments. They must also meet certain health criteria to join the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with glioblastoma multiforme (GBM) that has returned after initial treatments, including chemotherapy or radiotherapy with temozolomide.
  • Evidence of cancer progression on an MRI scan after previous treatment.
  • Have a measurable tumor of at least 1 cm in size on an MRI scan done within 21 days before starting the study drug.
  • Stable or decreasing dose of steroids for at least 5 days before the baseline MRI.
  • On a stable dose of any necessary medications, such as anticonvulsants, for at least 3 weeks before starting the study drug.
  • Able to perform daily activities with an ECOG performance status of 0 to 2.
  • Expected to live at least 12 more weeks.
  • Completed all previous cancer treatments before starting the study drug.
  • Recovered from any side effects of previous cancer treatments, except for mild neuropathy or hair loss.

Exclusion Criteria

  • Have had three or more previous treatments for GBM.
  • Have another type of cancer, unless it was a non-serious skin cancer or cervical cancer that has been treated and disease-free for at least 2 years.
  • Have significant heart disease.
  • Have digestive issues that affect how the body absorbs medication, such as certain bowel diseases or surgeries.
  • Have a bleeding disorder.
  • Need urgent treatment for the primary disease.
  • Need treatment with a strong CYP3A4 inhibitor.
  • Have had a stroke or significant brain bleeding in the last 6 months.
  • Are pregnant or breastfeeding.
  • Have been treated with bevacizumab (Avastin) before.

Locations

FACILITYZIPCITYSTATE
Research Site90095-1769Los AngelesCalifornia
Research Site94304Palo AltoCalifornia
Research Site02114BostonMassachusetts
Research Site02215BostonMassachusetts
Research Site2215BostonMassachusetts
Research Site10021New YorkNew York
Research Site98684VancouverWashington

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