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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01555710




Registration number
NCT01555710
Ethics application status
Date submitted
12/03/2012
Date registered
15/03/2012
Date last updated
21/05/2013

Titles & IDs
Public title
Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
Scientific title
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study
Secondary ID [1] 0 0
IPM3002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-Stage Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Palifosfamide-tris
Treatment: Drugs - Etoposide
Treatment: Drugs - Carboplatin

Experimental: Palifosfamide-tris plus Carboplatin and Etoposide - Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.

Active Comparator: Carboplatin plus Etoposide - Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.


Treatment: Drugs: Carboplatin
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.

Treatment: Drugs: Palifosfamide-tris
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.

Treatment: Drugs: Etoposide
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.

Treatment: Drugs: Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Assessed every 12 weeks for survival until 1 year following completion of enrollment
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest)
Secondary outcome [2] 0 0
Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
Timepoint [2] 0 0
Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Secondary outcome [4] 0 0
Response Duration
Timepoint [4] 0 0
Time from the date of first objective response (partial or complete response), with subsequent confirmation, until the date of disease progression or the occurrence of death
Secondary outcome [5] 0 0
Safety parameters (number of adverse events as well as number of findings from physical examinations, ECGs, vital signs, and clinical laboratory results)using NCI CTCAE v. 4.03
Timepoint [5] 0 0
22 weeks

Eligibility
Key inclusion criteria
- Documented extensive-stage small cell lung cancer.

- Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung
cancer.

- ECOG Performance Status of 0, 1 or 2.

- Adequate bone marrow and organ function based on the results of protocol- specified
laboratory tests.

- Male and female patients must agree to use a highly reliable method of birth control
during study participation.

- Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previously untreated (non-irradiated), symptomatic brain metastases.

- Known allergy to any of the study drugs or their excipients.

- Any unstable or clinically significant concurrent medical condition that would, in the
opinion of the investigator, jeopardize the safety of a patient and/or their
compliance with the protocol, based on screening tests, physical examination and
medical history (as specifically defined in the clinical protocol).

- Any malignancy other than small cell lung cancer within the last 5 years prior to
randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin
cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and
curatively treated with no evidence of recurrent or residual disease. (Exception:
Subjects with a history of malignancy other than small cell lung cancer may be
enrolled after consultation with the medical monitor provided the patient's prognosis
is best defined by the extensive-stage small cell lung cancer).

- Currently pregnant or nursing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2015
Actual
Sample size
Target
548
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Southern Medical Day Oncology Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Delaware
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Michigan
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Minnesota
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New Jersey
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New Mexico
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New York
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Vermont
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Virginia
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Washington
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United States of America
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Wisconsin
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Canada
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Manitoba
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Canada
State/province [26] 0 0
Ontario
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Canada
State/province [27] 0 0
Quebec
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France
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Basse-normandie
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France
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Bretagne
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France
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Centre
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France
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Limousin, Lorraine
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France
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Pays de La Loire
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France
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Provence Alpes Cote D'azur
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France
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Rhone-alpes
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France
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Strasbourg
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Hungary
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Hajdu-bihar
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Hungary
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Heves
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Nahariya
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Israel
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Petah Tiqwa
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Italy
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Genova
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Italy
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Milano
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Italy
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Trento
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Poland
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Zachodniopomorskie
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Russian Federation
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Bashkortostan
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Russian Federation
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Moscow
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Russian Federation
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Primorskiy
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Russian Federation
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Tatarstan
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Russian Federation
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Chelaybinsk
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Russian Federation
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Ivanovo
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Yaroslavl
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Taiwan
State/province [59] 0 0
Taichung
Country [60] 0 0
United Kingdom
State/province [60] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alaunos Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to
evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with
extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and
Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio
to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at
the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and
disease-related symptoms. Tumor-related endpoints will be assessed according to the Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse
events as determined by National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim
analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and
efficacy of the study interventions and to monitor the overall conduct of the clinical trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01555710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01555710