Clinical Trials Register

Summary
EudraCT Number:	2012-001472-10
Sponsor's Protocol Code Number:	INCB24360-210
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-05-24
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

UK - MHRA

A.2

EudraCT number

2012-001472-10

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, PHASE 2 STUDY OF THE IDO INHIBITOR INCB024360 VERSUS TAMOXIFEN FOR SUBJECTS WITH BIOCHEMICAL-RECURRENT-ONLY EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL CARCINOMA, OR FALLOPIAN TUBE CANCER FOLLOWING COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY

A.3.1

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

A RANDOMIZED, OPEN-treatment, PHASE 2 STUDY OF THE IDO INHIBITOR INCB024360 compared with TAMOXIFEN FOR women WITH OVARIAN CANCER, that blood tests suggest is returning after COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY

A.3.2

Name or abbreviated title of the trial where available

Phase 2: INCB024360 verses Tamoxifen in patients with recurrent ovarian cancer

A.4.1

Sponsor's protocol code number

INCB24360-210

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	Incyte Corporation
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	Incyte Corporation
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	Incyte Corporation
B.5.2	Functional name of contact point	Incyte Corporation Call Centre
B.5.3	Address:
B.5.3.1	Street Address	Rt 141 & Henry Clay Road
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19880
B.5.3.4	Country	United States
B.5.4	Telephone number	18554633463
B.5.5	Fax number	13024252734
B.5.6	E-mail	RA@incyte.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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	INCB024360
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	INCB024360
D.3.9.3	Other descriptive name	(Z)-N-(3-Bromo-4-fluorophenyl)-N'-hydroxy-4-(2-(sulfamoylamino) ethylamino)-1,2,5-oxadiazole-3-carboximidamide
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100 and 300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Tamoxifen 20mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Chatfield Pharmaceuticals Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tamoxifen 20mg Tablets
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
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

BIOCHEMICAL-RECURRENT-ONLY EPITHELIAL OVARIAN CANCER, PRIMARY PERITONEAL CARCINOMA, OR FALLOPIAN TUBE CANCER FOLLOWING COMPLETE REMISSION WITH FIRST-LINE CHEMOTHERAPY

E.1.1.1

Medical condition in easily understood language

recurrent ovarian cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 efficacy based on PFS of INCB024360 versus tamoxifen among subjects with CA-125 elevation following complete remission with first-line chemotherapy for advanced disease by investigator.

E.2.2

Secondary objectives of the trial

To evaluate the CA-125 response rate (GCIG criteria).
To evaluate OS.
To determine efficacy based on PFS by independent central review.
To determine the safety and tolerability of INCB024360 in this population.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects who have received first-line chemotherapy, which must have been a platinum containing regimen.
• Subjects who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy at least (4 weeks for prior taxane and at least 8 weeks for bevacizumab) prior to randomization and recovered from toxicities to less than Grade 2.
• Subject must be currently in remission by clinical and radiological criteria (Response Evaluation Criteria for Solid Tumors [RECIST 1.1]).
 Clinical remission is defined as: asymptomatic and a negative physical examination.
 Scans are required postcompletion of platinum-containing therapy to document disease remission.
• Prior to the first-line regimen, CA 125 must have been elevated at first diagnosis, must have normalized with the first-line therapy/regimen, and is currently elevated:
 CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at least 1 week apart.
 CA 125 elevation must be at least 6 months from completion of first-line platinum-containing regimen and have not occurred while receiving maintenance therapy.
 Documentation of at least 1 normal CA 125 level at approximately 6 months (± 4 weeks) or greater after completion of first line therapy is required.
• Subjects must have available archived tumor tissue.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate renal, hepatic, and bone marrow function based on screening laboratory assessments.

E.4

Principal exclusion criteria

1.Subjects who are currently breastfeeding.
2.Subjects who have received any other prior antitumor therapy except for the first-line platinum-containing regimen with or without maintenance paclitaxel or bevacizumab.
3.Subjects with any unresolved toxicity greater than or equal to Grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.
4.Subjects who have had prior radiotherapy within 3 months of randomization and have not recovered from all radiotherapy-related toxicities, who have received radiation therapy to the chest within 3 months of randomization, or who have a history of radiation pneumonitis.
5.Subjects with prior malignancies other than EOC, PPC, or FTC for which the subject has not been disease free for 3 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
6.History of hepatitis or positive serology as follows:
a.Hepatitis B (HepB) screening testing required:
HepB SAg (hepatitis B surface antigen);
Anti-HepB SAg (antibody against hepatitis B surface antigen);
Anti-Hepatitis B core IgG (antibody against hepatitis B core antigen).
Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive anti-HepB SAg test as the only evidence of prior exposure may participate in the trial.
b.Hepatitis C screening testing required:
HCV-antibody (antibody against hepatitis C virus);
HCV-RNA (serum test for circulating virus, based on detecting RNA)
7.Subjects known to be HIV-positive.
8.Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving therapy for an autoimmune or inflammatory disease.
a.Subjects with vitiligo, thyroiditis or eczema, but otherwise not meeting criterion 12 may be enrolled. Individual cases can be discussed with the sponsor.
9.Subjects who are currently receiving therapy with a potent CYP3A4 inducer or inhibitor (Appendix C). Subjects may enter screening when therapy with the potent inhibitor or inducer is completed.
10.Use of any UGT1A9 inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period.
11.Subjects for who tamoxifen is contraindicated.
12.Subjects who are receiving any immunologically-based treatment for any reason, including chronic use of systemic steroid at doses ≥ 7.5 mg/day prednisone equivalents; use of inhaled or topical steroids is acceptable.
13.Subjects who have undergone an organ transplant(s) including allogeneic stem cell or bone marrow transplants.
14.Subjects being treated with a MAOI, or drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within 3 weeks prior to screening. See Appendix D for prohibited medications associated with MAO inhibition.
15.Subjects who have had prior SS (Boyer and Shannon 2005).
16.Subjects who have had major surgery within 4 weeks prior to screening, excluding the placement of vascular access.
17.Subjects with unstable cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment.
18.Subjects with any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome). Unable or unwilling to swallow tablets BID.
19.Subjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocol.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival, using RECIST 1.1 definition of objective progression as determined by the investigator.

E.5.1.1

Timepoint(s) of evaluation of this end point

The evaluation of tumor lesions will be every 8 weeks.

E.5.2

Secondary end point(s)

CA-125 response rate, using GCIG criteria
Duration of OS.
Progression-free survival using RECIST 1.1 definition of objective progression as determined by independent central review.
Evaluate safety and tolerability of INCB024360.

E.5.2.1

Timepoint(s) of evaluation of this end point

The treatment cycles of 28 days are defined and patients will be assessed at the start of each cycle.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LPLV

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

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

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

110

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)

expected normal treatment of that condition

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

2012-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-08-23

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