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

Phase 1

Completed

• Conditions: Hematological Malignancies

• Registration Number: NCT01830010
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Study Start: 2013-06-28
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2018-11
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

• Resting heart rate below 55

• Significant cardiac disease (such as arrhytmia, heart failure) or any significant condition which in the investigators opinion would make the patient ineligible

  • Previous allogeneic HSCT
  • Any drug required that is not compatible with KRP203 (e.g. beta-blockers or anti-thymocyte globulin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events as a Measure of safety	111 days	Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies

Secondary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)	111 days	The main PK parameters will be determined in whole blood using non-compartmental methods. Pk parameters being measured are: AUCtau AUC during a dosing interval (tau) of 24 hours \[h.ng/mL\] , AUCtauR Molar ratios between KRP203-P and KRP203 based on Cmax or AUCtau
Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)	111 days	Cmax Maximum (peak) blood drug concentration after drug administration \[ng/mL\]
Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration	111 days	Tmax Time to reach maximum (peak) concentration \[ng/mL\]
GVHD-free, relapse free survival	2 years post transplant	occurence of GVHD, disease relaps and death will be assessed

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zürich, Switzerland