Custirsen sodium при Немелкоклеточный рак легкого - Реестр клинических исследований

Обзор исследования

Статус

Завершенный

Условия

Немелкоклеточный рак легкого

Вмешательство/лечение

Лекарство: custirsen sodium

Подробное описание

OGX-011 is an experimental drug that has been shown to increase the effectiveness of commonly used cancer therapies such as chemotherapy, radiation and hormone therapy in several kinds of cancer types in animals. OGX-011 is being studied in the treatment of cancer patients in combination with chemotherapy. In humans, OGX-011 in combination with hormone therapy has been shown to decrease the tissue levels of a protein called clusterin, which can be overproduced in cancer cells. Clusterin has been found to block cell death and makes cells more resistant to cancer therapy. Gemcitabine (GEM), cisplatin (CIS) and carboplatin (CARB) have been approved by Health Canada and the Food and Drug Administration in the United States for the treatment of patients with lung cancer.

OGX-011 was administered as a 2-hr intravenous (IV) infusion on Days -7, -5, and -3 prior to Cycle 1, then weekly on Days 1, 8, 15 of each 21-day cycle; GEM was infused IV after OGX-011 on Days 1 and 8; either CIS or CARB was infused IV after GEM on Day 1 of each cycle. Six cycles of treatment were planned. Most patients received OGX-011 at 640 mg, but 3 patients received OGX-011 at 480 mg dose; OGX-011 dose groups were combined due to the small number of patients who received 480 mg.

Тип исследования

Интервенционный

Регистрация (Действительный)

85

Фаза

Фаза 2
Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Канада
- Alberta
  - Calgary, Alberta, Канада
    - Tom Baker Cancer Centre
- British Columbia
  - Surrey, British Columbia, Канада
    - BC Cancer Agency, Fraser Valley Centre
  - Vancouver, British Columbia, Канада
    - BC Cancer Agency, Vancouver Center
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Канада
    - Dr. H. Bliss Murphy Cancer Center
- Ontario
  - Barrie, Ontario, Канада
    - Royal Victoria Hospital of Barrie
  - London, Ontario, Канада
    - London Regional Cancer Centre
  - Ottawa, Ontario, Канада
    - Ottawa Hospital
  - Toronto, Ontario, Канада
    - Toronto Sunnybrook Regional Cancer Center
- Quebec
  - Ste-Foy, Quebec, Канада
    - Hopital Laval
Соединенные Штаты
- California
  - Los Angeles, California, Соединенные Штаты, 90033
    - LAC-USC Medical Center
  - Los Angeles, California, Соединенные Штаты, 90033
    - University of Southern California Norris
- New York
  - Albany, New York, Соединенные Штаты, 12208
    - New York Oncology Hematology
- Oregon
  - Portland, Oregon, Соединенные Штаты, 97239
    - Oregon Health and Science University
- South Carolina
  - Greenville, South Carolina, Соединенные Штаты, 29605
    - Cancer Centers of the Carolinas
- Texas
  - Dallas, Texas, Соединенные Штаты, 75246
    - Mary Crowley Medical Research Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria

Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and must not have had chemotherapy or biological therapy for their disease.
Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not amenable to either surgery or radiation therapy of curative intent.
Life expectancy of ≥ 12 weeks
If patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
Radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors [RECIST] (at least 10 mm in longest diameter by spiral computed tomography [CT] scan, or at least 20 mm by standard techniques).
ECOG status must be ≤ 1

Exclusion Criteria

Prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neoadjuvant treatment.
Presence of central nervous system (CNS) metastases, unless the patient has completed successful local therapy for CNS metastases, with the exception of leptomeningeal disease for which patients will be excluded. Patients must be off corticosteroids for at least 21 days prior to starting treatment.
Second 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 3 years previously with no evidence of recurrence).
Patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (This criteria is intended to exclude patients with stage IIIB disease, as defined by the presence of N3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Основная цель: Уход
Распределение: Н/Д
Интервенционная модель: Одногрупповое задание
Маскировка: Нет (открытая этикетка)

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen Временное ограничение: Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.	Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: >= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.	Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Progression-free Survival Временное ограничение: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.	Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.	All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.
Overall Survival Временное ограничение: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.	Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.	All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.
Effect of OGX-011 on Serum Clusterin Levels Временное ограничение: Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1	To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.	Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1
Cmax of OGX-011 Временное ограничение: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.	Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.	Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.
t1/2 of OGX-011 Временное ограничение: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.	Plasma half life of OGX-011	Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.
AUC-0-last Временное ограничение: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.	AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)	Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Achieve Life Sciences

Следователи

Главный следователь: Janessa Laskin, M.D., BCCA, Vancouver Clinic

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Laskin JJ, Nicholas G, Lee C, Gitlitz B, Vincent M, Cormier Y, Stephenson J, Ung Y, Sanborn R, Pressnail B, Nugent F, Nemunaitis J, Gleave ME, Murray N, Hao D. Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer. J Thorac Oncol. 2012 Mar;7(3):579-86. doi: 10.1097/JTO.0b013e31823f459c.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 ноября 2004 г.

Первичное завершение (Действительный)

1 марта 2010 г.

Завершение исследования (Действительный)

1 марта 2010 г.

Даты регистрации исследования

Первый отправленный

26 августа 2005 г.

Впервые представлено, что соответствует критериям контроля качества