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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2004-004340-42-DE
Date of registration:	12/09/2005
Prospective Registration:	No
Primary sponsor:	Antisoma Research Ltd
Public title:	An Open Label, Randomized, Phase I/II Study of DMXAA in Combination with Carboplatin and Paclitaxel in Patients with Locally Advanced and Metastatic Non-Small Cell Lung Cancer. - Not applicable
Scientific title:	An Open Label, Randomized, Phase I/II Study of DMXAA in Combination with Carboplatin and Paclitaxel in Patients with Locally Advanced and Metastatic Non-Small Cell Lung Cancer. - Not applicable
Date of first enrolment:	06/04/2005
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004340-42
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Germany

Contacts

Name:
Address:
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Email:
Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
Histologically confirmed NSCLC

Stage IIIb and IV

Chemotherapy-naive patients (localised palliative irradiation is allowed)

Patient is not a candidate for radical radiotherapy

Minimum 18 years of age

Have a Karnofsky performance status of equal or more that 70%

Have a life expectancy of equal or more that 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
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)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Major surgery within the previous 4 weeks, chemotherapy or radiation therapy (except palliative)

Hypersensitivity to paclitaxel, carboplatin or their excipients

Previous exposure to DMXAA or other vascular targeting agents

SCLC or mixed forms

Receipt of blood infusions or growth factors within 2 weeks before baseline

Active serious infections within 2 weeks before baseline

Significant arrhythmias or known QTc prolongation

Uncontrolled systemic disease

Alcoholism, psychiatric disorder, pregnancy, childbearing potential or lactating women.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with histologically confirmed locally advanced or metastatic NSCLC (Stage IIIb/IV) without prior chemotherapy will be included. Patients must have at least one unidimensionally measurable lesion according to the RECIST criteria. CNS metastases, major surgery, chemotherapy or radiation therapy excluded in the previous 4 weeks are exclusion criteria.

Intervention(s)

Product Name: 5,6 Dimethylxanthenone-4-acetic acid
Product Code: AS1404
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AS1404
Other descriptive name: DMXAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Paclitaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Product Name: Carboplatin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Carboplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: Determination of the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) NSCLC

Primary end point(s): Objective response rates (complete and partial), time to progression (TTP), duration of response and stable disease, median and one year survival.

Secondary Objective: Determine a safe dose of DMXAA when administered in combination with satandard carbopaltin and paclitaxel therapy

Determine the safety and tolerability of the combination

Measure the tumor response rate and time to progression

Measure the duration of response and stable disease

Measure median and one year survival

Assess the potential for drug interaction between DMXAA and paclitaxel and carboplatin in combination.

Secondary Outcome(s)

Secondary ID(s)

AS1404-201

Not applicable

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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