CLR_15_03 = Safety, Tolerability and Pharmacokinetics of K0706 [Asia, Europe, USA]

Study title

Safety, Tolerability and Pharmacokinetic Study of K0706

Scientific title

A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) (EudraCT 2016-001754-18, ClinicalTrials.gov NCT02629692)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are willing and able to give written, and dated, informed consent
- are at least 18 years old
- are willing and able to comply with the scheduled visits
- have been diagnosed with Philadelphia chromosome positive (Ph+) in chronic phase (CML-CP), advanced phase (CML-AP) or blast phase (CML BP), or Ph+ Acute lymphoblastic leukemia (ALL)
-- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate organ and immune system function

Short description of intervention

This is an open-label dose-escalation study to determine the safety, tolerability, pharmacokinetics and activity of the novel tyrosine kinase inhibitor K0706.

Part A of the study in healthy volunteers has been completed. Part B of the study in patients is ongoing.

Type of study

7. Other trials

Current status

Recruiting

Part A of the study in healthy volunteers has been completed.
Part B of the study in patients is ongoing.

Study sponsor

Sun Pharma Advanced Research Company (SPARC) Limited, India

Scientific lead / contact

Geetanjali Chimote, MBBS,PhD, SPARC

Principal investigator

Mudgal Kothekar, MD, SPARC

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Belgium
Antwerpen
SPARC Site 1

Leuven
SPARC Site 1


France

Pierre-Bénite
SPARC Site 7


India

Madurai
SPARC Site 14

Mumbai
SPARC Site 15


Korea, Republic of

SPARC Site 25
Seoul, 06591


United States

Texas
SPARC Site 21
Houston, 77030

The study is also planned to be performed in the Czech Republic, Italy, Poland and the United Kingdom.

 

PONDEROSA [Germany]

Study title

PONDEROSA = Observational study with ponatinib

Scientific title

Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose

Indication and most important inclusion criteria

The study includes patients aged 18 years and older with chronic myeloid leukemia (CML) in any phase on treatment with ponatinib at any dose. Eligible for inclusion are patients who fulfill all inclusion criteria and have given their written consent to participate in the observational study.

Short description of intervention

Further data is needed to characterize the safety profile of ponatinib in routine clinical use in Europe. This observational study will render a realistic picture of the routine clinical use of ponatinib. It will also provide further information on the number and type of adverse events including their outcome in CML patients in any phase treated with ponatinib.

Type of study

Other trial

Current status

recruiting

Study sponsor

Friedrich-Schiller-Universität Jena, Germany, with financial support from Incyte Inc.

Scientific lead / contact

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Principal investigator

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Additional information

Study summary by Universitätsklinikum Jena in German

Study centers / principal investigators

Germany

Uniklinik der RWTH Aachen
Aachen

Studienzentrum Aschaffenburg
Aschaffenburg

Klinikum Augsburg
Augsburg

Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum
Berlin

Internistische FA-Praxis Prof. Josting
Berlin

Praxis Dr. Heßling
Berlin

Onkologische Praxis An der Wertach
Bobingen

St. Vincenz-Krankenhaus
Datteln

Gemeinschaftspraxis Mohm / Prange-Krex
Dresden

Universitätsklinikum Essen
Essen

Onkologische Schwerpunktpraxis
Esslingen

Centrum für Hämatologie und Onkologie Bethanien
Frankfurt/M

Klinikum Goch
Goch

MVZ Onkologische Kooperation Harz
Goslar

Universitätsklinikum Greifswald
Greifswald

OncoResearch Lerchenfeld GmbH
Hamburg

Universitätsklinikum Halle
Halle

Universitätsklinikum Jena
Jena

St. Ansgar Krankenhaus Höxter
Höxter

Praxis Dr. Steinmetz
Köln

Universitätsklinikum Leipzig
Leipzig

Gemeinschaftspraxis Dres. Müller, Kröning, Jentsch-Ullrich und Tietze
Magdeburg

Universitätsmedizin Mannheim
Mannheim

Rotkreuzklinikum München
München

Schick Hämatologisch-Onkologische Praxisgemeinschaft
München

Hämatologisch-onkologische Schwerpunktpraxis
Neustadt a. Rbge.

Klinikum Passau
II. Medizinische Klinik
Passau

Onkologische SPP Porta Westfalica
Porta Westfalica

Onkologiezentrum Soest
MVZ Kloster Paradiese
Soest

Onkologische Praxis und Tagesklinik Stuttgart
Stuttgart

Klinikum Traunstein
Traunstein

Universitätsklinikum Ulm
Ulm

Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen

Gemeinschaftspraxis für Hämatologie und Onkologie Dr. med. Reichert
Westerstede

MVZ des Marien-Hospital Witten
Witten

Gemeinschaftspraxis Dres. Bock
Wittenberge

Cancer Center Zweiseenland GbR Wolfratshausen
Wolfratshausen

 

OMNI = Registry to evaluate vascular occlusive events with Iclusig [US]

Study title

An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With Iclusig® (OMNI)

Scientific title

A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With Iclusig® (Ponatinib) in Routine Clinical Practice in the US (OMNI) (ClinicalTrials.gov NCT02455024)

Indication and most important inclusion criteria

Adult patients with chronic myeloid leukemia in chronic phase (CP-CML), chronic myeloid leukemia in accelerated phase (AP-CML), chronic myeloid leukemia in blast phase (BP-CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom the decision to initiate treatment with commercially available Iclusig has already been made
 

Inclusion Criteria:

1. Adult patients (age ≥18 years) who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL.

2. Patients who are initiating Iclusig therapy for the first time, or for whom Iclusig therapy was initiated within 30 days before registry enrollment.

3. The decision to prescribe Iclusig must have been made prior to enrollment in the registry and based upon approved US indications.

4. Patients who have the ability to understand the requirements of the registry, and provide verbal informed consent to comply with the registry data collection procedures.

Short description of intervention

Additional information is needed to characterize the safety profile of Iclusig as it is used in routine clinical practice in the US. This registry study will collect information about patient demographics, leukemia diagnosis, previous anti-cancer treatments, history of cardiovascular disease, risk factors for vascular complications, and concurrent medications (including antiplatelet and/or anticoagulant agents). 

Type of study

Other trials

Current status

Recruiting

Study sponsor

Ariad Pharmaceuticals (recently acquired by Takeda)
Collaborator: United BioSource Corporation

Scientific lead / contact

Blythe Thomson, MD

Principal investigator

For OMNI, there is no principal investigator as this is a registry.

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

EU PAS register

Study centers / principal investigators

United States

New Jersey
Hackensack, 07601
John Theurer Cancer Center at Hackensack UMC (Site 128)
Stefan Faderl, MD

New York
Hawthorne, 10532
Hudson Valley Hematology Oncology Associates (Site 236)
Karen Seiter, MD

Prospective Registry of Ponatinib in Belgium [Belgium]

Study title

Prospective registry of ponatinib in clinical practice for CML or Ph+ ALL in Belgium

Scientific title

Prospective registry of Iclusig® (ponatinib) used in clinical practice for the treatment of patients with Chronic Myeloid Leukemia or CML or Ph+ Acute Lymphoblastic Leukemia in Belgium

Indication and most important inclusion criteria

This registry will be open to all patients who:
- Received Iclusig® through the named patient program (NPP) prior to 01 March 2016 AND were still on Iclusig® treatment on 01 March 2016.
- Were put on Iclusig® treatment between 01 March 2016 and registry start.
- Will be put on Iclusig® treatment up to 3 years after reimbursement of Iclusig® in Belgium (01 March 2019).

Inclusion criteria:

1. Patients aged 18 years or older at time of starting treatment with Iclusig®.

2. Patients with a confirmed diagnosis of Chronic Myeloid Leukemia (CML) (chronic, accelerated or blast phase) who are resistant or intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation;
OR
Patients with a confirmed diagnosis of Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) who are resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.
3. Patients on treatment with Iclusig® or who have been prescribed treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).

The patient must not be included in the registry if he/she is concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).

Short description of intervention

This prospective registry aims to gather specific data on Iclusig® usage in routine practice on treatment dosage and duration up to 3 years after reimbursement in Belgium.

Secondary objectives are:
- To describe demographic and disease characteristics for patients with CML or Ph+aLL receiving Iclusig®.
- To describe Iclusig® treatment outcomes.
- To estimate the additional health care utilisation cost associated with the treatment of Iclusig® related adverse events reported during the registry

Type of study

Other trials

Current status

Recruiting

Study sponsor

Incyte

Scientific lead / contact

Prof. Timothy Devos, UZ Leuven, Belgium

Principal investigator

There is no principal investigator as this is a registry.

Additional information

Study centers / principal investigators

Belgium

UZ Leuven
Prof. Timothy Devos
Herestraat 49
3000 Leuven

The registry is open to all hemato-centers in Belgium with patients on ponatinib.

 

CALLS = CML and ALL Low Level Mutation Study in the UK [UK]

Study title

CALLS Study = CML and ALL Low Level Mutation Study

Scientific title

A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing. (ClinicalTrials.gov no NCT03647215)

Indication and most important inclusion criteria

Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent tyrosin kinase inhibitor (TKI).

Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:

BCR-ABL/ABL IS transcripts > 10% at 3 months
BCR-ABL/ABL IS transcripts > 1% at 6 months
BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later OR
Ph+ve ALL patients with any level of BCR-ABL/ABL IS transcripts who are not eligible for UKALL 14 or are not currently enrolled in UKALL 14

Short description of intervention

This is an observational study to establish the prevalence of mutations in patients with CML who meet the ELN criteria for warning or failure and patients with Ph+ ALL with detectable BCR-ABL currently being treated with first or subsequent TKI therapy in the UK.

Type of study

Other trials

Current status

Recruiting

Study sponsor

Incyte Biosciences UK

Scientific lead / contact

Study Director: Michael Thompson, MD Incyte Biosciences UK

Principal investigator

Hugues de Lavallade

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study description on the NHS website

Study centers / principal investigators

UK

Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ

Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW

Derriford Hospital
Plymouth, Devon, PL6 8DH

Queen's Hospital
Romford, Essex, RM7 0AG

Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY

Medway Maritime Hospital
Gillingham, Kent, ME75NY

Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR

Royal Oldham Hospital
Manchester, Lancashire, OL1 2JH

Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH

Ipswich Hospital
Ipswich, Suffolk, IP4 5PD

Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS

Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ

King's College Hospital
London, SE5 9RS

 

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]

Study title

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy

Scientific title

Observational study on CML patients in any phase of the disease, treated with ponatinib (Iclusig®)

Indication and most important inclusion criteria

This study includes patients who:
- are aged ≥18 years and agree to participate in the study
- are presenting CML in any phase
- have been receiving treatment with ponatinib for less than six months
- have the ability to understand the requirements of the study and to comply with the study data collection procedures

Short description of intervention

This is a non-interventional study. Ponatinib will be prescribed in the usual manner in accordance with the terms of the marketing authorization. All treatment decisions are made at the discretion of the patient’s healthcare provider (HCP) as per indication and are not mandated by the study design or protocol.

The study aims at better qualifying the benefit-risk balance of ponatinib in real life and in relation with the treatment history of CML patients therapeutic history.

The patient's health status will be evaluated during a 24-month follow-up. Time points for patient evaluation will be at the discretion of the investigator. It is anticipated that these will occur approximately every 3 months the first year, and then every 6 months.

• Effectiveness will be assessed on the basis of hematologic, cytogenetic and molecular response rates and survival duration (overall and progression-free) according to the center practices.
• Tolerance will be assessed by the collection of adverse events.

Type of study

Other trial

Current status

recruiting

Study sponsor

INCYTE BioSciences France

Scientific lead / contact

Prof. Ali Turhan

Principal investigator

Prof. Ali Turhan
Paris Sud University Hospitals-Bicetre & Paul Brousse
Research Director, Inserm U935 & INGESTEM Pluripotent Stem Cell Infrastructure
78 Rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France 

Additional information

 

Study centers / principal investigators

France

Paris Sud University Hospitals
Prof. Ali Turhan

 

 

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