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NCT01074138 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by Athenex.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01074138: Completed Phase 2 study, sponsored by Athenex.
NCT01074138 is a Phase 2 study that has completed, run by Athenex. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01074138, a Phase 2 study, has completed, sponsored by Athenex.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease progression in patients who have not had prior chemotherapy.
Primary Outcome
At screening/baseline, target lesions will be identified and measured by CT scan and bone lesions will be enumerated by bone scintigraphy. At 12 and 24 weeks after treatment with KX2-391, patients will be assessed by CT and bone scan to assess whether radiographic progression has occurred. At monthly visits and throughout the study, clinical progression will be evaluated.
Interventions
- DRUG KX2-391
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT01074138 record still lists
NCT01074138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which KX2-391 is the first listed.
NCT01074138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01074138 about?
NCT01074138 is a clinical study titled "Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer". The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease prog...
What is the current status of trial NCT01074138?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-02. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01074138?
The interventions under investigation include: KX2-391 (DRUG).
Who is sponsoring clinical trial NCT01074138?
This trial is sponsored by Athenex, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01074138's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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