A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects with Glioblastoma Multiforme

Completed

• Conditions: Glioblastoma; 10029211; Grade 4 Brain tumor

• Registration Number: NL-OMON41552
• Lead Sponsor: AbbVie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified