Trials / Completed
CompletedNCT02590263
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 20 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Whole Brain Radiation | Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site. |
| DRUG | Temozolomide | Temozolomide will be administered per label. |
| DRUG | ABT-414 | ABT-414 will be administered by intravenous infusion |
Timeline
- Start date
- 2015-08-24
- Primary completion
- 2020-08-27
- Completion
- 2020-08-27
- First posted
- 2015-10-29
- Last updated
- 2020-09-03
Locations
22 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02590263. Inclusion in this directory is not an endorsement.