A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01630733
Recruitment Status : Recruiting
First Posted : June 28, 2012
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
Achieve Life Sciences

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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Custirsen Drug: Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: 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
Other Names:
  • OGX-011
  • TV-1011
Drug: Docetaxel
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.
Drug: Docetaxel
Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 60 months ]
    Primary endpoint and variable for the study is overall survival (OS), defined as the time from date of randomization to the date of death from any cause.

Secondary Outcome Measures :
  1. Progression Free Survival per RECIST v1.1 [ Time Frame: 60 months ]
    Progression Free Survival: time from date of randomization to first objective documented progression per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Tumor lesions measured in at least one dimension with minimum size of 10 mm by CT scan, 10 mm caliper by clinical exam. Malignant lymph nodes must be >15 mm in short axis when assessed by CT scan. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total representative of all involved organs should be identified as target lesions and measured and recorded.

  2. Objective Response Rate as defined by RECIST v1.1. [ Time Frame: 60 months ]
    Objective Response (OR) is defined as achieving a best overall response of complete response (CR) or partial response (PR), as defined using RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  3. Duration of Disease Control [ Time Frame: 60 months ]
    The Duration of Disease Control is defined as the time from randomization to the date of the first documented disease progression (taking as reference for progressive disease the smallest measurements recorded on study) or death, whichever occurs first.

  4. Adverse events [ Time Frame: 60 months ]
    Adverse events and concomitant medications will be collected throughout the study up to 28 days after the last dose of study treatment. Medical history will be assessed, mutation status will be collected, if available, and an electrocardiogram will be performed at screening. Physical examination, vital signs, and laboratory evaluations will be conducted at screening and throughout the study.

  5. Duration of Objective Response [ Time Frame: 60 months ]
    The evaluation of overall response at each assessment is a composite of target lesion response, non-target lesion response, presence of new lesions.

  6. Disease Control Rate [ Time Frame: 60 months ]
    The disease control rate will be calculated as the total number of patients in each group with best overall response of CR, PR or Stable Disease (SD) divided by the total number of randomized patients in the group and will be compared similarly as Objective Response Rate (ORR.)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01630733

Contact: Oncogenex Pharmaceuticals (425) 686-1500

  Hide Study Locations
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States
University Cancer Institute Recruiting
Soynton Beach, Florida, United States
United States, Illinois
Joliet Oncology-Hematology Associates Ltd. Recruiting
Joliet, Illinois, United States
United States, Kentucky
Kentucky Cancer Clinic Recruiting
Hazard, Kentucky, United States
United States, Missouri
Missouri Baptist Cancer Center Recruiting
St. Louis, Missouri, United States
United States, North Carolina
Novant Health Recruiting
Winston Salem, North Carolina, United States
United States, Ohio
MetroHealth Medical Center Not yet recruiting
Cleveland, Ohio, United States
United States, Tennessee
Center for Biomedical Research LLC Recruiting
Knoxville, Tennessee, United States
United States, Texas
Blood and Cancer Center of East Texas Recruiting
Tyler, Texas, United States
United States, Virginia
Virginia Cancer Specialists PC Recruiting
Fairfax, Virginia, United States
Flinders Medical Centre Not yet recruiting
Bedford Park, Australia
Austin Health Recruiting
Heidelberg, Australia
Royal Hobart Hospital Recruiting
Hobart, Australia
St George Hospital Recruiting
Kogarah, Australia
Cabrini Hospital Malvern Recruiting
Malvern, Australia
Port Macquarie Base Hospital Recruiting
Port Macquarie, Australia
Border Medical Oncology Recruiting
Wodonga, Australia
The Queen Elizabeth Hospital Not yet recruiting
Woodville, Australia
Asklepios Fachkliniken GmbH Recruiting
Gauting, Germany
Martha-Maria Krankenhaus Halle-Dolau gGmbH Recruiting
Halle (Saale), Germany
Klinikum Kassel Recruiting
Kassel, Germany
Kliniken der Stadt Koln gGmbH Not yet recruiting
Koeln, Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet Recruiting
Budapest, Hungary
Országos Korányi TBC és Pulmonológiai Intézet Recruiting
Budapest, Hungary
Uzsoki Utcai Korhaz Recruiting
Budapest, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet Recruiting
Szolnok, Hungary
Meir Medical Center Recruiting
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Az. Osp. Univ. Ospedali Riuniti Umberto I G.M. Lancisi G.Salesi Active, not recruiting
Ancona, Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy
Azienda Ospedaliera Istituti Ospitalieri Recruiting
Cremona, Italy
Istituto Nazionale per la Ricerca sul Cancro Recruiting
Genova, Italy
Ospedale Livorno Recruiting
Livorno, Italy
Azienda Ospedaliera - Ospedale San Carlo Borromeo Recruiting
Milano, Italy
Azienda Ospedaliera Niguarda Ca Granda Recruiting
Milano, Italy
Azienda Ospedaliero Universitaria di Parma Active, not recruiting
Parma, Italy
IRCCS Policlinico San Matteo Not yet recruiting
Pavia, Italy
Korea, Republic of
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of
Keimyung University Dongsan Medical Center Active, not recruiting
Daegu, Korea, Republic of
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Jeonnam, Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Palmerston North Hospital Not yet recruiting
Palmerston North, New Zealand
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie Recruiting
Olsztyn, Poland
Med-Polonia Sp. z o.o. Recruiting
Poznan, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu Not yet recruiting
Poznan, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego Not yet recruiting
Szczecin, Poland
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary Recruiting
Arkhangelsk, Russian Federation
Federal State Institution Medical Radiology Research Center Recruiting
Obninsk, Russian Federation
Oncology Centre Number 2 Recruiting
Sochi, Russian Federation
Consorcio Hospitalario Provincial de Castellon Not yet recruiting
St. Petersburg, Russian Federation
Leningrad Regional Clinical Hospital Recruiting
St. Petersburg, Russian Federation
SOC Clinic @ Farrer Park Not yet recruiting
Singapore, Singapore
Fundacion Hospital de Alcorcon Recruiting
Alcorcon, Spain
Hospital del Mar Recruiting
Barcelona, Spain
Consorcio Hospitalario Provincial de Castellon Not yet recruiting
Castellon, Spain
Hospital Universitario Insular Materno-Infantil de Las Palmas Not yet recruiting
Las Palmas de G.C., Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda-Madrid, Spain
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Spain
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain
Changhua Christian Hospital Not yet recruiting
Changhua City, Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
National Cheng Kung University Hosptial Recruiting
Tainan, Taiwan
Tri-Service General Hospital Active, not recruiting
Taipei, Taiwan
Prapokklao Hospital Not yet recruiting
Chanthaburi, Thailand
Songklanagarind Hospital Prince of Songkla University Recruiting
Hat Yai, Songkhla, Thailand
Maharat Nakhonratchasima Hospital Active, not recruiting
Nakhon Ratchasima, Thailand
National Cancer Institute Not yet recruiting
Phayathai, Bangkok, Thailand
Buddhachinnaraj Hospital Not yet recruiting
Phisanulok, Thailand
Saraburi Regional Hospital Not yet recruiting
Saraburi, Thailand
Municipal Institution Clinical Oncology Dispensary of Dnipropetrovsk Regional Council Not yet recruiting
Dnipropetrovsk, Ukraine
Municipal institution Multifield City Clinical Hospital Numero 4 of Dnipropetrovsk Regional Council Recruiting
Dnipropetrovsk, Ukraine
MIHC Kharkiv Regional Clinical Oncology Center Recruiting
Kharkiv, Ukraine
Ukrainian Medical Stomatological Academy Not yet recruiting
Poltava, Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary Recruiting
Sumy, Ukraine
Uzhgorod Central City Clinical Hospital Recruiting
Uzhgorod, Ukraine
Vinnytsya Regional Clinical Oncology Dispensary Recruiting
Vinnytsya, Ukraine
Sponsors and Collaborators
Achieve Life Sciences

Responsible Party: Achieve Life Sciences Identifier: NCT01630733     History of Changes
Other Study ID Numbers: TV1011-LC-303
2012‐002447‐14 ( EudraCT Number )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Keywords provided by Achieve Life Sciences:
Stage IV
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action