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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830010
• Other study ID #: CKRP203A2105
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2013
• Est. completion date: August 21, 2018

Study information

• Verified date: November 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

• Patients aged 18 to 65 years, inclusive

• Patients must have a hematological malignancy that as per standard medical practice requires myeloablative conditioning (including short term myeloablative reduced intensity conditioning) followed by allogeneic hematopoetic stem cell transplant

• Karnofsky Performance status =60%.

• Suitable stem cell source available according to the graft selection algorithm using T-cell replete peripheral stem cells as a graft source

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)

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Intervention

Drug:
• Study Part 1: KRP203
All subjects will receive KRP203 for 111 days
• Study Part 2: KRP203 lower dose

• Study Part 2: KRP203 higher dose

Locations

Country	Name	City	State
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Regensburg	Bavaria
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a Measure of safety	Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies	111 days
Secondary	Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)	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	111 days
Secondary	Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)	Cmax Maximum (peak) blood drug concentration after drug administration [ng/mL]	111 days
Secondary	Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration	Tmax Time to reach maximum (peak) concentration [ng/mL]	111 days
Secondary	GVHD-free, relapse free survival	occurence of GVHD, disease relaps and death will be assessed	1 years post-transplant
Secondary	GVHD-free, relapse free survival	occurence of GVHD, disease relaps and death will be assessed	2 years post transplant

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com
•   Results for CKRP203A2105 can be found on the Novartis Clinical Trial Results Website