Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

Phase 1

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: ABT-414; Drug: Temozolomide; Radiation: Whole Brain Radiation

• Registration Number: NCT01800695
• Lead Sponsor: AbbVie

Brief Summary

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Study Start: 2013-04-02
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Status Verified: 2017-07
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

1. Glioblastoma Multiforme (GBM)
2. 70 or above on Karnofsky Performance Status
3. Adequate bone marrow function
4. Recurrent GBM per RANO criteria
5. Subjects must have confirmed EGFR amplification by central lab

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Exclusion Criteria

1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
3. Allergies to temozolomide, dacarbazine, IgG containing agents
4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
5. Subjects that have had more than one disease recurrence

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Whole Brain Radiation	ABT-414 in combination with radiation and temozolomide
Arm B	ABT-414	ABT-414 in combination with temozolomide
Arm A	ABT-414	ABT-414 in combination with radiation and temozolomide
Arm B	Temozolomide	ABT-414 in combination with temozolomide
Arm C	ABT-414	ABT-414 monotherapy
Arm A	Temozolomide	ABT-414 in combination with radiation and temozolomide

Primary Outcome Measures

Name	Time	Method
Number and percentage of participants with adverse events	Every week for an expected average of 34 weeks	Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Maximum concentration of ABT-414	Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks	Measurement of the maximum concentration of ABT- 414 in the blood
Number of Dose Limiting Toxicities	Every week for an expected average of 34 weeks	Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Minimum Concentration of ABT-414	Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks	Measurement of the minimum concentration of ABT-414 in the blood
Half-life of ABT-414	Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks	Measurement of the clearance of ABT-414

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination	The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months
Biomarker EGFR expression	At screening and post-study	Assessment of tumor biomarkers that may correlate with efficacy.
Progression Free Survival	Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.	Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.