Intellance1

A Study of an Active Drug in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

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

Status:
Completed
Conditions:
Glioblastoma
Gliosarcoma
Enrollment:
691 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M13-813
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

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.

All the cities where the clinical studies are located

Halifax - B3H 1V7
Hamilton - L8V 1C3
London - N6A 4L6
Ottawa - K1H 8L6
Toronto - M5G 2M9
Montreal - H1T 2M4
Montreal - H3T 1E2
Montreal - H4A 3J1
Montréal - H2X 0A9
Quebec City - G1R 2J6
Quebec City - G1R 2J6
Sherbrooke - J1H 5N4
Winnipeg - R3E 0V9

More information about this study

clinicaltrials.gov