A Phase I, Open Label, Multicenter, Parallel-group, Single Dose Two-staged Study to Evaluate the Pharmacokinetics and Safety of a Single 400 mg Oral Dose of LEE011 in Subjects With Varying Degrees of Impaired Renal Function Compared to Matched Healthy Volunteers With Normal Renal Function
Phase of Trial: Phase I
Latest Information Update: 17 Nov 2017
At a glance
- Drugs Ribociclib (Primary)
- Indications Breast cancer; Cancer; Liposarcoma; Lymphoma; Non-small cell lung cancer; Soft tissue sarcoma
- Focus Pharmacokinetics
- Sponsors Novartis Pharmaceuticals
- 10 Nov 2017 Planned End Date changed from 30 Oct 2017 to 4 May 2018.
- 08 May 2017 Planned End Date changed from 28 Apr 2017 to 30 Oct 2017.
- 08 May 2017 Planned primary completion date changed from 13 Apr 2017 to 30 Oct 2017.