Intellance1
Brief summary
This study seeks to determine whether the addition of an active drug to concomitant radiotherapy and temozolomide (TMZ) followed by combination of an active drug with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of an active drug in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 99 Years.
Inclusion Criteria:
- Must have a clinical diagnosis of glioblastoma (GBM).
- Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
- Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to
randomization (N/A to the sub-study).
- Must have recovered from effects of surgery, postoperative infection and other
complications of surgery.
- Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the
participant must have adequate bone marrow and renal function and have
mild-to-moderate hepatic impairment).
Exclusion Criteria:
- Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the
participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or
metastatic GBM).
- Prior chemo therapy or radiosensitizer for head and neck cancer.
- Prior radiotherapy to the head or neck in overlap of radiation fields.
- Prior therapy for glioblastoma or other invasive malignancy.
- Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF),
EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or
intracavity anti-neoplastic therapy.
