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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/NCT01630733




Registration number
NCT01630733
Ethics application status
Date submitted
26/06/2012
Date registered
28/06/2012
Date last updated
1/07/2016

Titles & IDs
Public title
A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
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
Secondary ID [1] 0 0
2012-002447-14
Secondary ID [2] 0 0
TV1011-LC-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-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 - Custirsen
Treatment: Drugs - Docetaxel

Experimental: Custirsen + Docetaxel - Custirsen: Three loading doses of custirsen 640mg IV over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle

Active Comparator: Docetaxel - Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent or protocol specified parameters to stop treatment.


Treatment: Drugs: Custirsen
Custirsen: Three loading doses of custirsen 640 mg IV over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle

Treatment: Drugs: Docetaxel
Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
60 months
Secondary outcome [1] 0 0
Progression Free Survival per RECIST v1.1
Timepoint [1] 0 0
60 months
Secondary outcome [2] 0 0
Objective Response Rate as defined by RECIST v1.1.
Timepoint [2] 0 0
60 months
Secondary outcome [3] 0 0
Duration of Disease Control
Timepoint [3] 0 0
60 months
Secondary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
60 months
Secondary outcome [5] 0 0
Duration of Objective Response
Timepoint [5] 0 0
60 months
Secondary outcome [6] 0 0
Disease Control Rate
Timepoint [6] 0 0
60 months

Eligibility
Key inclusion criteria
1. Patients must have a histologically or cytologically confirmed, unresectable, advanced
or metastatic (Stage IV per AJCC 7th edition 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 performance status of 0 or 1 at screening.

8. Have adequate values, 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)

- AST and ALT = 1.5 x ULN

9. Resolution of any toxic effects of prior therapy to Grade =1 according to 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. Men of
reproductive potential who are not surgically sterile must agree to abstain from
sexual activity or use medically accepted and highly effective method of contraception
during and for 6 months after the 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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;
patients 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 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.

11. Patients with known and documented EGFR mutation who have not received an EGFR
inhibitor.

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
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2017
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [6] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [7] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment postcode(s) [6] 0 0
- Port Macquarie
Recruitment postcode(s) [7] 0 0
- Wodonga
Recruitment postcode(s) [8] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
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United States of America
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Kentucky
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United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
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North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
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United States of America
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Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Germany
State/province [10] 0 0
Gauting
Country [11] 0 0
Germany
State/province [11] 0 0
Halle (Saale)
Country [12] 0 0
Germany
State/province [12] 0 0
Kassel
Country [13] 0 0
Germany
State/province [13] 0 0
Koeln
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Szolnok
Country [16] 0 0
Israel
State/province [16] 0 0
Kfar Saba
Country [17] 0 0
Israel
State/province [17] 0 0
Tel Aviv
Country [18] 0 0
Italy
State/province [18] 0 0
Ancona
Country [19] 0 0
Italy
State/province [19] 0 0
Bergamo
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Italy
State/province [20] 0 0
Cremona
Country [21] 0 0
Italy
State/province [21] 0 0
Genova
Country [22] 0 0
Italy
State/province [22] 0 0
Livorno
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Parma
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Italy
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Pavia
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonnam
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Korea, Republic of
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Seongnam
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
New Zealand
State/province [32] 0 0
Christchurch
Country [33] 0 0
New Zealand
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Palmerston North
Country [34] 0 0
Poland
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Olsztyn
Country [35] 0 0
Poland
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Poznan
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Poland
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Szczecin
Country [37] 0 0
Russian Federation
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Arkhangelsk
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Russian Federation
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Obninsk
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Russian Federation
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Sochi
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Alcorcon
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Spain
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Barcelona
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Spain
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Castellon
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Spain
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Las Palmas de G.C.
Country [46] 0 0
Spain
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Madrid
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Spain
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Majadahonda-Madrid
Country [48] 0 0
Spain
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Sabadell
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Spain
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Valencia
Country [50] 0 0
Taiwan
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Changhua City
Country [51] 0 0
Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Chanthaburi
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Thailand
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Hat Yai, Songkhla
Country [56] 0 0
Thailand
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Nakhon Ratchasima
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Thailand
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Phayathai, Bangkok
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Thailand
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Phisanulok
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Thailand
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Saraburi
Country [60] 0 0
Ukraine
State/province [60] 0 0
Dnipropetrovsk
Country [61] 0 0
Ukraine
State/province [61] 0 0
Kharkiv
Country [62] 0 0
Ukraine
State/province [62] 0 0
Poltava
Country [63] 0 0
Ukraine
State/province [63] 0 0
Sumy
Country [64] 0 0
Ukraine
State/province [64] 0 0
Uzhgorod
Country [65] 0 0
Ukraine
State/province [65] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Achieve Life Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to compare overall survival of patients randomized to
receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive
docetaxel alone (Arm B).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01630733
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
Oncogenex Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
(425) 686-1500
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01630733