Etude : CLR_15_03 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CLR_15_03

Nom :

Traitement : Induction

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 29/06/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : 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)

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : DETAILED DESCRIPTION:
- Part A ( for Healthy volunteers) of the study is completed
- Part B (for CML subject ) of the study is ongoing only in India, other countries completed.

- Part C of study in subjects with CML is on-going in all mentioned countries except India. --- Open for Recruitment ---

STUDY DESIGN:
Part C: Single Group Assignment -> K0706 capsules 174 mg, once daily, oral
•Cohort A: For CML subjects in CP at study entry
•Cohort B: For CML subjects in AP at study entry
•Cohort C: For CML subjects in BP at study entry:

PRIMARY OBJECTIVE (Part C):
• Evaluate the anti-leukemic efficacy of K0706 in subjects with CML-CP by cytogenetic outcomes and in subjects with AP and BP by hematologic outcomes who have failed ≥ 3 TKIs one of which includes ponatinib

SECONDARY OBJECTIVES (Part C):
• Anti-leukemic efficacy of K0706 by molecular outcomes
• Anti-leukemic efficacy of K0706 by hematological outcomes in CML-CP
• Anti-leukemic efficacy of K0706 by cytogenetic outcomes in CML-AP & BP
• Time to first hematologic response
• Duration of response
• Progression free survival (PFS) and Overall survival (OS)
• Population PK of K0706
• Safety of K0706 in the dosed subjects

Phase : I/II

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable - inclusion of subjects needing legally acceptable representative/impartial witness will be in compliance to the enrolling country's regulatory requirement) and is available for the entire study
2.Willing and able to comply with the scheduled visits, treatment plan,
laboratory testing, study procedures, and restrictions, and be accessible
for follow-up
3.Subjects with Ph+CML CP, AP or BP who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib. (Subjects with Ph+ ALL are not included)
4.Male or female aged ≥ 18 years
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0,
1, or 2
6.Adequate organ and immune system function as indicated by the
following laboratory values obtained ≤ 2 weeks prior to IMP
administration.
7.Subjects of childbearing potential must practice a medically acceptable
method of birth control as judged by the Investigator (refer to protocol
for details)
8.Male subjects enrolled in the study should not father a child and are
advised to prevent passage of semen to their sexual partner during
intercourse using an acceptable method as detailed in the Inclusion
criteria # 7 and judged by the Investigator for the duration of the study
and for 3 months after the last IMP administration
9.Female subjects of childbearing potential must have a negative
pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human
chorionic gonadotropin).
10.Female subjects must be non-lactating and non-breast-feeding

--- Other criteria may apply (refer to protocol) ---

Critères de non-inclusion : 1.Presence of T315I mutations
2.Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
3.Inability to swallow oral medication
4.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical
laboratory test findings which in the opinion of the investigator may
jeopardize the safety of the patient during the study or may interfere
with the evaluation of the study medication.
5.Positive tests: urine pregnancy tests (if applicable), HIV
6.History of any relevant allergy/hypersensitivity (including known
immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to the IMP or its excipients)
7.Known history of active hepatitis B or hepatitis C
8.Received an investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
9.Use of concomitant medication that might influence the results of the
study prior to IMP administration/or anticipated need any time during
the study
10.Known or suspected history of alcohol abuse or excessive intake of alcohol in the 12 months prior to study entry
11.Known or suspected history of significant drug abuse as judged by the Investigator
12.Radiotherapy or cytotoxic chemotherapy within 21 days or Vincristine
within 7 days (for Ph+ ALL only); interferon or Cytarabine or
immunotherapy within 14 days prior to the first IMP administration visit
13.Active central nervous system (CNS) disease as evidenced by
cytology or pathology.
14.Malabsorption syndrome or other illness that could affect oral
absorption of the IMP
15.Clinically significant, uncontrolled, or active cardiovascular disease
16.Uncontrolled intercurrent illness
17.Subjects eligible and willing to undergo bone marrow transplant
18.Autologous or allogeneic stem cell transplant ≤ 3 months prior to
Screening
19.Another primary malignancy within the past 3 years or earlier.
20.Any contraindications for repeated bone marrow sample collection
21.Prior exposure to K0706 therapy as a participant in Part B of the
protocol

--- Other criteria may apply (refer to protocol) ---
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02629692
Promoteur :
Sun Pharma Advanced Research Company Limited
Type de sponsor : Industriel
Sun Pharma Advanced Research Company Limited
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Valérie Coiteux

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : À VENIR

MAJ : 29/06/2020