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NCT01237236 · ClinicalTrials.gov registry record · Phase 1
A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 156
- Enrollment target
NCT01237236 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 156 participants.
The verdict
NCT01237236, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 156 participants
- Enrollment target
Study Summary
LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor models in animals. Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease the ability of the bone marrow to make white blood cells, platelets, and red blood cells. Although these effects are expected to be reversible, they can increase the risk of infection, bleeding and fatigue. The primary purpose of this study is to find the highest dose of LEE011 that can be safely given to adult patients with advanced solid tumors or lymphomas for which no further effective standard treatment is available. It will provide information about the side effects that may occur following treatment. The study will also possibly provide early evidence for LEE011's anti-tumor activity.
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2010-12-21 |
| Est. Completion | 2017-03-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01237236
The ClinicalTrials.gov registry entry for NCT01237236 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LEE011 is the first listed.
NCT01237236 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01237236 about?
NCT01237236 is a clinical study titled "A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.". LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence ...
What is the current status of trial NCT01237236?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 156 participants. The study started on 2010-12-21. Estimated completion is 2017-03-09.
What interventions are being tested in trial NCT01237236?
The interventions under investigation include: LEE011 (DRUG).
Who is sponsoring clinical trial NCT01237236?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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