Clinical Trials Register

Summary
EudraCT Number:	2010-019214-25
Sponsor's Protocol Code Number:	AXP-CT-001
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-07-06
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

Sweden - MPA

A.2

EudraCT number

2010-019214-25

A.3

Full title of the trial

Safety, pharmacokinetics and efficacy of AXP107-11 in combination with standard gemcitabine (Gemzar®) treatment in patients with locally advanced or metastatic, unresectable, adenocarcinoma of the pancreas, stage III-IV. A prospective, open label, multi-centre, sequential phase Ib/IIa study.

A.4.1

Sponsor's protocol code number

AXP-CT-001

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	Axcentua Pharmaceuticals AB
B.1.3.4	Country	Sweden
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role
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	Gemzar®
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Sweden AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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	Gemzar® (Gemcitabin)
D.3.4	Pharmaceutical form	Powder for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	GEMCITABINE HYDROCHLORIDE
D.3.9.1	CAS number	122111-03-9
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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.3.1	Product name	AXP107-11
D.3.2	Product code	AXP107-11
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	4',5,7-trihydroxyisoflavone-Na-dihydrate
D.3.9.2	Current sponsor code	AXP107-11
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	100
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Histologically confirmed, unresectable, locally advanced or metastatic pancreatic cancer stage III-IV

E.1.1.1

Medical condition in easily understood language

Pancreatic cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10033606
E.1.2	Term	Pancreatic cancer non-resectable
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10033605
E.1.2	Term	Pancreatic cancer metastatic
E.1.2	System Organ Class	100000004864

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

Primary objectives

Phase Ib
The primary objective is to determine the safety profile and MTD of AXP107-11 alone and when given in combination with gemcitabine standard therapy.
Safety will be assessed by occurrence of adverse events, abnormal changes in laboratory parameters, vital signs, ECG and relevant patient withdrawal.

Phase IIa
The primary objective is to assess the effect of a combination therapy of AXP107-11 and gemcitabine on objective response rate defined as the percentage of patients who showed complete response (CR) or partial response (PR).

E.2.2

Secondary objectives of the trial

Phase Ib
To determine the pharmacokinetic (PK) profile of escalating doses of AXP107-11 when given alone and in
combination with gemcitabine.

Phase IIa
To assess the;
- safety and tolerability of a combination therapy of AXP107-11 and gemcitabine.
- effect of a combination therapy of AXP107-11 and gemcitabine on overall survival (OS).
- effect of a combination therapy of AXP107-11 and gemcitabine on overall survival rate.
- effect of a combination therapy of AXP107-11 and gemcitabine on time to progression.
- effect of a combination therapy of AXP107-11 and gemcitabine on palliation.
- effect of a combination therapy of AXP107-11 and gemcitabine on clinical benefit response.
- effect of combination therapy of AXP107-11 and gemcitabine on the tumor mass using positron emission
tomography.
- effect of a combination therapy of AXP107-11 and gemcitabine on symptom distress score.
- effect of a combination therapy of AXP107-11 and gemcitabine on quality of life.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria
1. Age ≥ 18 years at the time of signing the informed consent
2. Histologically confirmed adenocarcinoma of the pancreas
3. Metastatic or locally advanced, unresectable disease stage III-IV.
4. Measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid tumors (RECIST) for target lesions
5. Karnofsky Performance Status ≥ 70 at study entry (Appendix 18.4).
6. Life expectancy of more than three months
7. Negative pregnancy test for female patients
8. For fertile women, willingness to perform double-barrier contraception during study and for four weeks after last treatment
9. Able and willing to sign the informed consent form

E.4

Principal exclusion criteria

Exclusion criteria
1. Previous or ongoing severe supraventricular or ventricular arrhythmia
2. Previous or ongoing coagulation or bleeding disorder (PTT > 1.5 x ULN)
3. HIV infection
4. Known hypersensitivity to any component of the AXP107-11 formulation or gemcitabine
5. Previous or ongoing significant liver pathology (other than metastases) and/or liver function disorders
6. Previous or ongoing significant chronic renal dysfunction
7. Previous or ongoing malignancy other than pancreatic cancer < five years prior to enrolment, except basal cell carcinoma treated locally
8. Cardiovascular disease, New York Heart Association (NYHA) classification III or IV
9. Severe pulmonary obstructive or restrictive disease
10. Acute or chronic inflammation (autoimmune or infectious)
11. Significant active/unstable non-malignant disease likely to interfere with study assessments
12. Laboratory tests (hematology, chemistry) outside specified limits:
- WBC ≤ 3 x 10³/mm³
- ANC ≤ 1.5 x 10³/mm³
- Platelets ≤ 100.000/mm³
- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
- PT/PTT > 3 x ULN
- Serum creatinine > 130 µmol/l) or clearance < 60 ml/min
- AST and/or ALT > 3 x ULN with the exception of patients with liver metastasis (> 5 x ULN)
- Alkaline phosphatase > 3 x ULN
- Total bilirubin > 3 x ULN

13. Immunotherapy within six weeks prior to enrolment.
14. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
15. Any radiotherapy for pancreatic adenocarcinoma before enrolment except for treatment of bone metastases if target lesions are not included in the irradiated field
16. Major surgery within four weeks prior to enrolment
17. Pregnant or nursing woman
18. Participations in other interventional clinical study within four weeks of enrolment

E.5 End points

E.5.1

Primary end point(s)

• Karnofsky Performance Status scale (KPS)
• Clinical Benefit Response (CBR) according to a modified Burris scheme
• Tumor response (RECIST)
• Tumor marker CA19-9 (for confirmation of tumor response)
• Exploratory biomarkers
• Positron Emission Tomography (PET) /computed tomography (CT)
• Quality of life by EORTC QLQ-C30 questionnaire and PAN26 module
• Symptom severity assessment using the Edmonton Symptom Assessment System (ESAS)
• Survival status

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

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Phase Ib/IIa

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

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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

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.1.3

Elderly (>=65 years)

Yes

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)

AXP107-11 will be administered in combination with gemcitabine until disease progression, severe toxicity, patient withdrawal or during a maximum of six months, whichever comes first.

For patients with documented tumor response (CR, PR) or SD and no intolerable toxicity after six months’ combination treatment, AXP107-11 treatment may be continued during the long-term follow up, after approval by Axcentua Pharmaceuticals AB.

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

2010-08-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-07

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