NCT01830010

A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies

A Two-part, Single- and Two Arm Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy (in Part 2 Only) of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	Study Part 1: KRP203	All subjects will receive KRP203 for 111 days
DRUG	Study Part 2: KRP203 lower dose
DRUG	Study Part 2: KRP203 higher dose

Timeline

• Start date: 2013-06-28
• Primary completion: 2018-08-21
• Completion: 2018-08-21
• First posted: 2013-04-11
• Last updated: 2020-12-11

Locations

8 sites across 3 countries: France, Germany, Switzerland