Clinical Trials Register

Summary
EudraCT Number:	2011-004151-39
Sponsor's Protocol Code Number:	0761-007
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-16
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2011-004151-39

A.3

Full title of the trial

Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) in Subjects with Previously Treated Peripheral T-cell Lymphoma (PTCL)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical trial study to determine if KW-0761, an antibody, will work in patients with recurrent or unsuccessfully treated Peripheral T-Cell Lymphoma (PTCL) and to evaluate its side effects.

A.4.1

Sponsor's protocol code number

0761-007

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Kyowa Hakko Kirin Pharma, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Kyowa Hakko Kirin Pharma Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Kyowa Hakko Kirin Pharma, Inc.
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	212 Carnegie Center, Suite 101
B.5.3.2	Town/ city	Princeton
B.5.3.3	Post code	NJ 08540
B.5.3.4	Country	United States
B.5.4	Telephone number	0016099191100
B.5.5	Fax number	0016099191111
B.5.6	E-mail	Ptcl007@kyowa-kirin-pharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	POTELIGEO
D.2.1.1.2	Name of the Marketing Authorisation holder	Kyowa Hakko Kirin Co., Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Japan
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/11/943
D.3 Description of the IMP
D.3.1	Product name	KW-0761(Mogamulizumab)
D.3.2	Product code	KW-0761
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	mogamulizumab
D.3.9.1	CAS number	1159266-37-1
D.3.9.2	Current sponsor code	KW-0761
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Treatment of patients with relapsed or refractory PTCL

E.1.1.1

Medical condition in easily understood language

Treatment of a rare type of cancer affecting white blood cells

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10034626
E.1.2	Term	Peripheral T-cell lymphoma unspecified refractory
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL

E.2.2

Secondary objectives of the trial

To determine the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory PTCL treated with KW 0761
To further assess the safety of KW-0761
To describe the immunogenicity of KW-0761

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1)Voluntarily signed and dated Ethics Committee (EC) approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure;
2)Males and female subjects ≥ 18 years of age at the time of enrollment;
3)Histologically confirmed diagnosis of PTCL according to World Health Organization (2008) classification as specified below;
a.PTCL-NOS
b.Angioimmunoblastic T-cell lymphoma
c.Anaplastic large cell lymphoma, ALK-positive
d.Anaplastic large cell lymphoma, ALK-negative
e.Transformed mycosis fungoides
4)Failed or intolerant of at least one prior systemic anticancer therapy;
5)Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry;
6)At least one site of disease measurable in two dimensions by computed tomography (CT). Both nodal and extranodal disease will be considered (lymph nodes must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm)
7)Subjects who are positive for CCR4 by immunohistochemistry.
8)The subject has resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCICTCAE, v.4.0) excluding the specifications required in 9, 10, and 11 below;
9)Adequate hematological function:
a.absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3);
b.platelets ≥ 100,000 cells/μL (≥ 100,000/mm3) or ≥ 75,000 cells/μL (≥ 75,000/mm3)in the presence of known bone marrow involvement.
Note: Retesting for values out of criteria will be permitted;
10)Adequate hepatic function:
a.bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN)except for subjects with Gilbert’s Syndrome;
b.aspartate transaminase (AST) and alanine transaminase (ALT)
each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.
Note: Retesting for values out of criteria will be permitted;
11)Adequate renal function as evidenced by serum creatinine of ≤1.5 x the ULN or a calculated creatinine clearance of ≥ 60 ml based on the Cockroft-Gault algorithm.
Note: Retesting for values out of criteria will be permitted;
12)Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication;
13) WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.
WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months);
14) Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception (defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.

E.4

Principal exclusion criteria

1)Subject with the following PTCL diagnoses are excluded;
a.Precursor T/NK neoplasms
b.Adult T-cell leukemia-lymphoma
c.T-cell prolymphocytic leukemia
d.T-cell large granular lymphocytic leukemia
e.Aggressive NK-cell leukemia
f.Systemic EBV-positive T-cell lymphoproliferative disorder of childhood
g.Hydroa vacciniforme-like lymphoma
h.Mycosis fungoides, other than transformed mycosis fungoides
i.Sezary Syndrome
j.Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphatoid papulosis
k.Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell lymphoma
l.Primary cutaneous CD4+ small/medium T-cell lymphoma
m.Primary cutaneous gamma-delta T-cell lymphoma
n.Extranodal NK /TT-cell lymphoma-nasal type
o.Enteropathy-associated T-cell lymphoma
p.Hepatosplenic T- cell lymphoma
q.Subcutaneous panniculitis -like T-cell lymphoma
r.Chronic lymphoproliferative disorder of NK cells
2)Have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or
localized prostate cancer with a current PSA of ≤ 0.1 ng/ml who is currently without evidence of disease.
3)Relapsed less than 75 days of autologous stem cell transplant
4)History of allogeneic stem cell transplant
5)Evidence of central nervous system (CNS) metastasis.
6)Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
7)Subjects with a history of moderate or severe psoriasis (covering >3% body surface area) or with psoriasis associated with systemic symptoms
e.g. arthropathy, or with a 1st degree relative with history of psoriasis that required medical intervention.
8)Significant uncontrolled intercurrent illness including, but not limited to:
a.uncontrolled infection requiring antibiotics;
b.clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification);
c.unstable angina pectoris;
d.angioplasty, stenting, or myocardial infarction within 6 months;
e.uncontrolled hypertension (systolic blood pressure >160 mm Hg or
diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications;
f.clinically significant cardiac arrhythmia; or
g.uncontrolled diabetes.
9)Known or tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
10)Active herpes simplex or herpes zoster:
a.Subjects with a history of herpes zoster who have had an outbreak
within the last 3 months will also be excluded;
b.Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed
medication for the duration of the study.
11)Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
12)Known active autoimmune disease will be excluded (For example: Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
13)Is pregnant (confirmed by beta-human chorionic gonadotrophin [β-HCG]) or lactating.
14)Prior treatment with KW-0761;
15)Initiation of treatment with systemic corticosteroids while on study is only permitted for acute and brief complications of underlying disease (e.g.,hypercalcemia) or for treatment related side effects. Subjects on systemic corticosteroids prior to enrollment must be off for 7 days before initiation of treatment with KW-0761. All tests to document extent of disease must be performed after completion of corticosteroid treatment and prior to first infusion of KW-0761 (subjects may receive intra-articular corticosteroid injections, intraocular
corticosteroid drops, inhalation or nasal corticosteroids and replacement doses of systemic or steroids as needed);
16)Initiation of treatment with topical corticosteroids while on study is not permitted except to treat an acute rash. Assessment of skin disease must be documented after completion of corticosteroid treatment and before treatment with KW-0761 is reinitiated;
17)Have had anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 4 weeks of commencing treatment;
18)Subjects treated with any immunomodulatory drug for concomitant or intercurrent
conditions other than T-cell lymphoma or who received any of these agents within 4 weeks of treatment including, but not limited to low dose or oral methotrexate; azathioprine; intravenous (iv)
immunoglobulin low dose or oral; cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; abatacept; rituximab; anakinra; interferon-α; interferon-β; IL-2, lenalidomide and natalizumab.

E.5 End points

E.5.1

Primary end point(s)

To determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL

E.5.1.1

Timepoint(s) of evaluation of this end point

Refer to protocol

E.5.2

Secondary end point(s)

To determine the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory PTCL treated with KW 0761

To further assess the safety of KW-0761

To describe the immunogenicity of KW-0761

E.5.2.1

Timepoint(s) of evaluation of this end point

Refer to protocol

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will revert back to their primary physician for further evaluation

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-01

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IMP with orphan designation in the indication
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