A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy

• Register: EUCTR
• Last refreshed on: 12 February 2018
• Main ID: EUCTR2012-002447-14-IT
• Date of registration: 21/12/2012
• Prospective Registration: Yes
• Primary sponsor: TEVA PHARMACEUTICALS INDUSTRIES LTD
• Public title: A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy
• Scientific title: A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV- 1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer - ENSPIRIT
• Date of first enrolment: 28/01/2013
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002447-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: yes; Other specify the comparator: Docetaxel 75mg/m2 EV il G1 di ogni cliclo di 21gg; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, China, Georgia, Germany, Hungary, Israel, Italy, Korea, Republic of, New Zealand, Philippines, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, United States, Vietnam

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Teva Pharma GmbH

• Name: Clinical Trial Information Desk
• Affiliation: Teva Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1.Patients must have a histologically or cytologically confirmed,
unresectable, advanced or metastatic (Stage IV per American Joint
Committee on Cancer 7th edition of tumor, nodes and metastases
classification of malignant tumors [TNM] staging) NSCLC
2.Males or females = 18 years of age at screening.
3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
4.Patients must have received one prior line of platinum-based systemic
anticancer therapy for advanced or metastatic NSCLC. Prior maintenance
therapy is allowed and will be considered as the same line of therapy
when continued at the end of a treatment regimen.
5.Patients must have documented radiological disease progression
either during or after the first-line therapy.
6.Patients must have at least one measurable lesion per RECIST 1.1
criteria.
7.ECOG PS of 0 or 1 at screening.
8.Have adequate bone marrow, renal and liver functions at screening as
defined below:
-Absolute neutrophil count (ANC) = 1.5 x 109/L
-Platelet count = 100 x 109/L
-Hemoglobin = 9 g/dL
-Serum creatinine = 1.5 x upper limit of normal (ULN)
-Total Bilirubin=1.0 x ULN (unless elevated secondary to benign
conditions such as Gilbert's disease)
-Aspartate transaminase (AST) and alanine transaminase (ALT)=1.5 x
ULN
9.Resolution of any toxic effects of prior therapy to Grade =1 according
to the National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and =
Grade 2 peripheral neuropathy).
10.Females of child-bearing potential must have negative serum
pregnancy test within 72 hours before randomization.
11.Women of child-bearing potential will practice a highly effective
method of birth control during and for 3 months after the
chemotherapy/custirsen last dose. Male partners of women of childbearing
potential can be either surgically sterile, or will ensure that their
female partner utilizes a highly effective contraceptive method during
and for 3 months after chemotherapy/custirsen last dose.
12.Patients must be willing and able to give written informed consent
prior to any protocol-specific procedures being performed and comply
with the protocol requirements for the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 660

Exclusion criteria:
1.Patients treated with any systemic anti-cancer therapy for NSCLC
within 21 days prior to randomization (6 weeks for bevacizumab).
2.Radiotherapy = 2 weeks prior to randomization. Patients must have
recovered from all radiotherapy-related toxicities.
3.Major surgical procedure within 4 weeks prior to randomization.
Patient must have recovered from all surgery-related complications.
4.Patients with known central nervous system (CNS) metastases
(Patients with any clinical signs of CNS metastases must have a CT or
MRI of the brain to rule out CNS metastases in order to be eligible for
participation in the study. Patients who have had brain metastases
treated with radiotherapy or surgically removed with no residual disease
confirmed by imaging should be clinically stable and off corticosteroid
treatment at least 3 weeks prior to randomization).
5.Patients with current diagnosis or a history of another active primary
malignancy (except in situ carcinoma of the cervix, adequately treated
non-melanomatous skin cancers, clinically localized prostate cancer,
superficial bladder cancer or other malignancy treated at least 5 years
previously with no evidence of recurrence).
6.Severe or unstable medical conditions such as heart failure, ischemic
heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus,
psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (= Grade 2, according to NCI CTCAE v4.0) or any
other significant or unstable concurrent medical illness that in the
opinion of the Investigator would preclude protocol therapy.
7.A history of events such as myocardial infarction, cerebrovascular
accident (CVA) or acute hepatitis within 3 months of randomization or
treatment of a major active infection within one month of randomization,
or any other significant event that in the opinion of the Investigator
would preclude protocol therapy.
8.Planned concomitant participation in another clinical trial of an
experimental agent, vaccine, or device. Concomitant participation in
observational studies is acceptable.
9.Female patients who are breastfeeding.
10.Patients previously treated with docetaxel for NSCLC or with known
severe hypersensitivity to taxane therapies.


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

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer stage IV
MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Custirsen
Product Code: OGX-011, TV-011
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: custirsen
CAS Number: 685922-56-9
Current Sponsor code: OGX-011, TV-011
Other descriptive name: Custirsen 20mg/ml concentrato per soluzione per infusione
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: date of death

Secondary Objective: Efficacy:
1.To compare Progression Free Survival (PFS) between patients
receiving docetaxel with or without custirsen.
2.To compare Objective Response Rate (ORR) between patients
receiving docetaxel with or without custirsen.
3.To compare Duration of Objective Response between patients
receiving docetaxel with or without custirsen
4.To compare Disease Control Rate (DCR) between patients receiving
docetaxel with or without custirsen
5.To compare Duration of Disease Control (DC), between patients
receiving docetaxel with or without custirsen.
Safety:
To assess the safety profile of custirsen in combination with docetaxel.

Primary end point(s): The primary endpoint and variable for the study is OS, defined as the
time from date of randomization to the date of death from any cause.

Main Objective: To evaluate if the combination regimen of custirsen and docetaxel
improves the Overall Survival (OS) of patients with advanced or
metastatic (Stage IV) NSCLC who have received one prior line of
platinum-based systemic anticancer therapy.

Secondary Outcome(s)

Secondary end point(s): -Progression Free Survival (PFS)
-Objective Response Rate (ORR)
-Duration of Objective Response
-Disease Control Rate (DCR)
-Duration of Disease Control

Timepoint(s) of evaluation of this end point: -PFS, defined as the time from the date of randomization to the first
objective documented progression per RECISTv1.1 or death due to any
cause,whichever occurs first.
-OR is defined as achieving a best overall response of CR or PR,as
defined using RECISTv1.1.
-Duration of OR is defined as time from first occurrence of CR or PR
(whichever is first recorded) until date of the first documented disease
progression or death, whichever occurs first.
-DC is defined as achieving a best overall response of CR, PR or SD.
-Duration of DC is defined as the time from randomization to the date of
the first documented disease progression or death, whichever occurs
first.

Secondary ID(s)

TV1011-LC-303

2012-002447-14-HU

Source(s) of Monetary Support

Teva Pharmaceutical Industries, Ltd.