Glioblastoma Grade 4 Brain tumor
Conditions
Interventions
Subjects will receive ABT-414 every other week by IV injection as monotherapy
or together with the standard of care medication (Temozolomide with or without
radiotherapy). Subjects can continue the
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Glioblastoma Multiforme (GBM); 70 or above on Karnofsky Performance Status; adequate bone marrow function, Arm A and Expanded Cohort Arm A: Subjects with newly diagnosed GBM; Arm B: Subject has recurrent GBM measureable criteria per RANO or newly diagnosed GBM and has just completed adjuvant radiation and/or TMZ therapy; Arm C and Expanded Cohorts B and C: (With recurrent GBM) Measurable disease per RANO criteria, and have an interval of at least 12 weeks from the completion of radiation therapy to study entry OR have progression which is clearly outside the radiation field.
Exclusion criteria
Exclusion criteria: For subjects in Arm A, Arm B and the Expanded Cohort with newly diagnosed GBM: Subject has received prior chemotherapy or radiotherapy for cancer in the head and neck region; Recurrent GBM in Arm B: no prior treatment bevacizumub, nitrosourea, more than 2 therapies, or has secondary GBM; Arm C and expanded cohort C with recurrent GBM: Prior treatment with bevacizumab for recurrent GBM, and secondary GBM; Allergies to temozolomide, decarbazine, IgG containing agents; Anti-cancer treatment 28 days prior to study Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of Arm A include: * Assessment of the safety of ABT-414 in combination with radiation and TMZ; * Determination of the maximum tolerated dose (MTD) of ABT-414 in combination with radiation and TMZ; * Determination of the Recommended Phase 2 Dose (RPTD) of ABT-414 in combination with radiation and TMZ; * Evaluation of ABT-414 pharmacokinetic profile when used in combination with radiation and TMZ. The primary objectives of Arm B include: * Assessment of the safety of ABT-414 in combination with TMZ; * Determination of the maximum tolerated dose (MTD) of ABT-414 in combination with TMZ; * Determination of the recommended Phase 2 Dose (RPTD) of ABT-414 in combination with TMZ; * Evaluation of ABT-414 and TMZ pharmacokinetic profiles when they are used in combination. The primary objectives of Arm C include: * Assessment of the safety of ABT-414 monotherapy; * Determination of the maximum tolerated dose (MTD) of ABT-414 monotherapy; * Determination of the recommended Phase 2 Dose (RPTD) of ABT-414; * Evaluation of ABT-414 pharmacokinetic profiles when used in monotherapy. The primary objectives of the Expanded Cohorts include: * Assessment of the safety of ABT-414 at the RPTD as monotherapy or in combination with RT and TMZ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters of Arm A, B and C: * Assessment of tumor biomarkers that may correlate with efficiency, including EGFR expression by ICH, FISH and PCR. Secondary parameter of all three the expansion cohorts is to further determine the safety of ABT-414 as monotherapy or in combination with TMZ and/or radiotherapy, in an extended population of patients. | — |
Countries
Netherlands
Outcome results
None listed