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NCT01026493 · ClinicalTrials.gov registry record · Phase 1
Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma
A Phase 1 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 257
- Enrollment target
NCT01026493: Completed Phase 1 study, sponsored by Radiation Therapy Oncology Group.
NCT01026493 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 257 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (328% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01026493, a Phase 1 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 257 participants
- Enrollment target
Study Summary
RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with temozolomide may kill more tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of giving veliparib together with temozolomide and to see how well it works in treating patients with recurrent glioblastoma.
Primary Outcome
Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (\>100.4). gr 4 neutropenia lasting \> 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ desp
Interventions
- DRUG temozolomide 60 mg x 21 days
- DRUG temozolomide 75 mg x 21 days
- DRUG ABT-888 20 mg x 21 days
- DRUG ABT-888 40 mg x 21 days
- DRUG Temozolomide 150 mg x 5 days
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2010-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01026493 record still lists
NCT01026493 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (328% higher).
The record links to 0 conditions, and to 5 interventions - of which temozolomide 60 mg x 21 days is the first listed.
NCT01026493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01026493 about?
NCT01026493 is a clinical study titled "Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma". RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib ...
What is the current status of trial NCT01026493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 257 participants. The study started on 2010-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01026493?
The interventions under investigation include: temozolomide 60 mg x 21 days (DRUG), temozolomide 75 mg x 21 days (DRUG), ABT-888 20 mg x 21 days (DRUG), ABT-888 40 mg x 21 days (DRUG), Temozolomide 150 mg x 5 days (DRUG).
Who is sponsoring clinical trial NCT01026493?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01026493's enrollment target sits among peer trials
257 168th of 2000 higher than 1,833 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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