Clinical Trials Register

Summary
EudraCT Number:	2007-004167-22
Sponsor's Protocol Code Number:	PGT307
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2007-11-20
Trial 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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2007-004167-22

A.3

Full title of the trial

Paclitaxel poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 30 pg/ml

A.4.1

Sponsor's protocol code number

PGT307

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Cell Therapeutics, 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
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	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	Paclitaxel poliglumex
D.3.2	Product code	CT-2103
D.3.4	Pharmaceutical form	Powder for solution 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	paclitaxel poliglumex
D.3.9.1	CAS number	263351-82-2
D.3.9.3	Other descriptive name	ester conjugate of alpha-poly-L-glutamic acid and paclitaxel
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	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	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	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	Paclitaxel
D.3.4	Pharmaceutical form	Concentrate for solution 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	paclitaxel
D.3.9.3	Other descriptive name	Taxol, Anzatax, Asotax, Bristaxol, Praxel
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	6
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: 3
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	Information not present in EudraCT
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	Carboplatin
D.3.4	Pharmaceutical form	Concentrate for solution 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	carboplatin
D.3.9.1	CAS number	41575-94-4
D.3.9.3	Other descriptive name	Paraplatin
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	10
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

Advanced Non-small Cell Lung Cancer (NSCLC) in women.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10029515
E.1.2	Term	Non-small cell lung cancer recurrent

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10029521
E.1.2	Term	Non-small cell lung cancer stage IIIB

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10029522
E.1.2	Term	Non-small cell lung cancer stage IV

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the overall survival of patients randomized to the CT-2103/carboplatin arm to that of patients randomised to the comparator arm (paclitaxel/carboplatin).

E.2.2

Secondary objectives of the trial

To compare the progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Women with baseline estradiol >30 pg/mL (Women on hormone replacement therapy are allowed if baseline estradiol >30 pg/mL).
2. Histologically- or cytologically-confirmed diagnosis of NSCLC. (Note: Sputum
cytology alone is not acceptable for cell type. Cytologic specimens obtained by
brushings, washings, or needle aspiration of a defined lesion or from a pleural
effusion are acceptable). Patients may have either measurable or nonmeasurable
disease according to RECIST.
3. ECOG performance score (PS) of 0, 1, or 2 defined as:
0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out
work of a light or sedentary nature, e.g., light house work, office work
2 = Ambulatory and capable of all self-care but unable to carry out any work
activities and up and about more than 50% of waking hours.
4. Patients must meet one of the following criteria:
• Recurrent disease following completion of radiation or surgery
• Stage IIIB who are not candidates for combined modality therapy (primary
radiation therapy or surgery), or
• Stage IV.
5. Age ≥18 years.
6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC)
≥1.5X 109/L and platelet count ≥100 X 109/L.
7. Hemoglobin ≥10 g/dL (may be achieved with transfusion).
8. Adequate renal function demonstrated by creatinine ≤ 1.5 X the upper limit of normal (ULN).
9. Adequate hepatic function demonstrated by all of the following
• Total bilirubin ≤ 1.5 ULN (CTC grade 1) (patients with Gilbert’s Syndrome or
other hereditary bilirubin defects may be included regardless of bilirubin levels)
and
• If liver metastases are not present, SGOT and SGPT ≤2.5 x ULN (CTC grade 0
or 1), otherwise SGOT and SGPT must be ≤5 x ULN (CTC grade 0 to 2).
• Alkaline phosphatase less than or equal to 2.5 x ULN except for elevated
alkaline phosphatase with laboratory documentation that demonstrates bone
origin.
10. Life expectancy ≥12 weeks
11. Patients with known brain metastases must have received standard antitumor
treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their
CNS metastases as defined by the site’s institutional standards. Neurologic function
must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen. Patients must have recovered from therapy for their brain metastases.
12. Patients who have had major surgery must be fully recovered from the surgery.
13. Ability to comply with the visit schedule and assessments required by the protocol.
14. For patients of reproductive potential, commitment to use adequate contraception during the study and for 6 months after the last dose of study drug.
15. Signed approved informed consent, with understanding of study procedures including follow-up for survival.
16. Agreement to begin study therapy within 8 calendar days after randomization.

E.4

Principal exclusion criteria

1. ECOG performance score (PS) of 0, 1, 3, or 4 defined as:
3 = Capable of only limited self-care, confined to bed or chair more than 50% of
waking hours
4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or
chair
2. Known hypersensitivity to the excipients or the study drug (either CT-2103,
paclitaxel, or carboplatin that the patient will receive.
3. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology.
4. Weight loss >10% in previous 6 months
5. LDH > 600 IU/L (central laboratory) regardless of weight loss
6. Both LDH > 400 IU/L (central laboratory) and ≥ 5% weight loss in previous 6
months
7. BMI >35
8. Any prior systemic chemotherapy for the treatment of lung cancer. This includes
systemic radiosensitizers used to treat brain metastases and any biologic agent.
9. Local palliative radiotherapy < 7 days before randomization.
10. Radiation with curative intent < 30 days before randomization.
11. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
12. Grade 2 or greater neuropathy.
13. Evidence of significant unstable neurological symptoms within the 4 weeks before
study randomization. (If unstable neurologic symptoms resulted from brain
metastases, patient must meet inclusion criteria number 10).
14. Clinically significant active infection for which active therapy is underway.
15. Investigational therapy within 4 weeks before randomization, unless local
requirements are more stringent.
16. Unstable medical conditions including unstable angina or myocardial infarction
within the past 6 months before randomization. Patients with evidence of cardiac
conduction abnormalities are eligible if their cardiac status is stable.
17. Pregnant women or nursing mothers.
18. Any circumstance at the time of study entry that would preclude completion of the
study or the required follow-up.

E.5 End points

E.5.1

Primary end point(s)

Overall Survival: The interval between the date of randomization and death due to
any cause. The overall survival for patients who are alive at their date of last
contact, including those lost to follow-up, will be censored at the date of last
contact.

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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.8.3

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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

End of trial is death. The median survival for the control group will be 6.5 months and for the study group 9.0 months.

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 months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

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

156

F.4.2.2

In the whole clinical trial

450

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)

End of participation in the trial is death.

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

2008-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-01-23

P. End of Trial
P.	End of Trial Status	Ongoing

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