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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). 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
Primary Outcome
Maximum tolerated dose of Zotiraciclib (TG02) in combination with dose dense Temozolomide (TMZ) was assessed using the Bayesian Optimal Interval (BOIN) design. The MTD is defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 0.35. If there are ties, we select the higher dose level when the isotonic estimate is lower than the target toxicity rate; and we select the lower dose level when the isotonic estimate is greater than the target t
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 |
Why NCT02942264 stopped before completion
NCT02942264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide (TMZ) is the first listed.
NCT02942264 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02942264's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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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