Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02942264 · ClinicalTrials.gov registry record · Phase 1
Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT02942264: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02942264 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02942264, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
Background: Zotiraciclib (TG02) is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors. Objective: To find out if Zotiraciclib (TG02) is safe, and to find out if it in combination with TMZ is as effective as TMZ alone in people with brain tumors. Eligibility: People ages 18 and older with a brain tumor that has progressed after standard treatment Design: In phase I part, the Bayesian optimal interval (BOIN) design will be used to find the maximum tolerated dose (MTD) of Zotiraciclib (TG02) for Arm 1 (dose dense TMZ) and Arm 2 (metronomic TMZ) independently. Then a randomized cohort expansion compared progression free survival at 4 months (PFS4) of the two arms for an efficient determination of a TMZ schedule to combine with Zotiraciclib at MTD. In Phase II part, a Bayesian design based on posterior probability will be used to monitor efficacy. Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Magnetic resonance imaging (MRI) of the brain if they have not had one in 14 days * Heart test * Tissue sample from prior surgeries Participants will take Zotiraciclib (TG02) plus TMZ by mouth in 28-day cycles. * Some will take TMZ for 7 days on and 7 days off. Others will take it every day. * They will all take Zotiraciclib (TG02) three days before Cycle 1, and then on four days during every cycle. * They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after each Zotiraciclib (TG02) dose. * They will all keep a diary of when they take the drugs and their symptoms. Participants will have study visits. These include: * Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4 weeks * Blood tests every 2 weeks Participants will continue treatment until their disease gets worse or they have intolerable side effects. Participants will also be enrolled in anot
Interventions
- DRUG Temozolomide (TMZ)
- DRUG Zotiraciclib (TG02)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-12-14 |
| Est. Completion | 2020-08-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02942264
The ClinicalTrials.gov registry entry for NCT02942264 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide (TMZ) is the first listed.
NCT02942264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02942264 about?
NCT02942264 is a clinical study titled "Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma". Background: Zotiraciclib (TG02) is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors. Objective: To find out if Zotiraciclib (TG02) is safe, and to find out if it in combination with TMZ is as effe...
What is the current status of trial NCT02942264?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2016-12-14. Estimated completion is 2020-08-26.
What interventions are being tested in trial NCT02942264?
The interventions under investigation include: Temozolomide (TMZ) (DRUG), Zotiraciclib (TG02) (DRUG).
Who is sponsoring clinical trial NCT02942264?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.