Clinical trial NCT01630733: A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Metastatic
Stage IV
Advanced
lung cancer
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 60 months
Secondary outcomes:
measure: Progression Free Survival per RECIST v1.1
timeFrame: 60 months
measure: Objective Response Rate as defined by RECIST v1.1.
timeFrame: 60 months
measure: Duration of Disease Control
timeFrame: 60 months
measure: Adverse events
timeFrame: 60 months
measure: Duration of Objective Response
timeFrame: 60 months
measure: Disease Control Rate
timeFrame: 60 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Soynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates Ltd.
state: Illinois
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: St. Louis
country: United States
facility: Missouri Baptist Cancer Center
state: Missouri
city: Winston Salem
country: United States
facility: Novant Health
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Knoxville
country: United States
facility: Center for Biomedical Research LLC
state: Tennessee
city: Tyler
country: United States
facility: Blood and Cancer Center of East Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists PC
state: Virginia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Heidelberg
country: Australia
facility: Austin Health
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Kogarah
country: Australia
facility: St George Hospital
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
city: Wodonga
country: Australia
facility: Border Medical Oncology
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
city: Gauting
country: Germany
facility: Asklepios Fachkliniken GmbH
city: Halle (Saale)
country: Germany
facility: Martha-Maria Krankenhaus Halle-Dolau gGmbH
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Koeln
country: Germany
facility: Kliniken der Stadt Koln gGmbH
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: Az. Osp. Univ. Ospedali Riuniti Umberto I G.M. Lancisi G.Salesi
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Livorno
country: Italy
facility: Ospedale Livorno
city: Milano
country: Italy
facility: Azienda Ospedaliera - Ospedale San Carlo Borromeo
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca Granda
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Obninsk
country: Russian Federation
facility: Federal State Institution Medical Radiology Research Center
city: Sochi
country: Russian Federation
facility: Oncology Centre Number 2
city: St. Petersburg
country: Russian Federation
facility: Consorcio Hospitalario Provincial de Castellon
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Singapore
country: Singapore
facility: SOC Clinic @ Farrer Park
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Castellon
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
city: Las Palmas de G.C.
country: Spain
facility: Hospital Universitario Insular Materno-Infantil de Las Palmas
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda-Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hosptial
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Chanthaburi
country: Thailand
facility: Prapokklao Hospital
city: Hat Yai, Songkhla
country: Thailand
facility: Songklanagarind Hospital Prince of Songkla University
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhonratchasima Hospital
city: Phayathai, Bangkok
country: Thailand
facility: National Cancer Institute
city: Phisanulok
country: Thailand
facility: Buddhachinnaraj Hospital
city: Saraburi
country: Thailand
facility: Saraburi Regional Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution Clinical Oncology Dispensary of Dnipropetrovsk Regional Council
city: Dnipropetrovsk
country: Ukraine
facility: Municipal institution Multifield City Clinical Hospital Numero 4 of Dnipropetrovsk Regional Council
city: Kharkiv
country: Ukraine
facility: MIHC Kharkiv Regional Clinical Oncology Center
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Oncology Dispensary
Study officials:
References: