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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800695
• Other study ID #: M12-356
• Secondary ID: 2012-003884-23
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2013
• Last updated: November 17, 2017
• Start date: April 2, 2013
• Est. completion date: June 19, 2017

Study information

• Verified date: July 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• ABT-414
ABT-414 will be administered by intravenous infusion
• Temozolomide
Temozolomide will be administered per label and local prescribing regulations.

Radiation:
• Whole Brain Radiation
Whole Brain radiation will be administered in 30 fractions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of participants with adverse events	Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)	Every week for an expected average of 34 weeks
Primary	Maximum concentration of ABT-414	Measurement of the maximum concentration of ABT- 414 in the blood	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
Primary	Number of Dose Limiting Toxicities	Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)	Every week for an expected average of 34 weeks
Primary	Minimum Concentration of ABT-414	Measurement of the minimum concentration of ABT-414 in the blood	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
Primary	Half-life of ABT-414	Measurement of the clearance 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
Secondary	Biomarker EGFR expression	Assessment of tumor biomarkers that may correlate with efficacy.	At screening and post-study
Secondary	Progression Free Survival	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.	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.
Secondary	Overall Survival	The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months	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

External Links

•   Abstract of study results