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| Sponsored by: |
Ascenta Therapeutics |
|---|---|
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00544960 |
Purpose
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: AT-101 and docetaxel Drug: placebo and docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment |
| Official Title: | A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC) |
| Estimated Enrollment: | 102 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
AT-101 and docetaxel
|
Drug: AT-101 and docetaxel
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
|
|
2: Placebo Comparator
placebo and docetaxel
|
Drug: placebo and docetaxel
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
|
Further Study Details provided by Ascenta.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Research Site | |
| Durham, North Carolina, United States | |
| Russian Federation | |
| Research Site | |
| Arkhangelsk, Russian Federation | |
| Research Site | |
| Chelyabinsk, Russian Federation | |
| Research Site | |
| Ekaterinburg, Russian Federation | |
| Research Site | |
| Samara, Russian Federation | |
| Research Site | |
| Kazan, Russian Federation | |
| Research Site | |
| Moscow, Russian Federation | |
| Research Sites (4) | |
| Saint Petersburg, Russian Federation | |
| Research Site | |
| Kaliningrad, Russian Federation | |
| Research Site | |
| Stavropol, Russian Federation | |
| Research Site | |
| Voronezh, Russian Federation | |
| Ukraine | |
| Research Site | |
| Dnipropetrovsk, Ukraine | |
| Research Site | |
| Donetsk, Ukraine | |
| Research Site | |
| Lugansk, Ukraine | |
| Research Site | |
| Zaporizhzhya, Ukraine | |
| Research Site | |
| Kharkiv, Ukraine | |
| Research Site | |
| Uzhgorod, Ukraine | |
| Research Site | |
| Kyiv, Ukraine | |
| Study Chair: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
| Responsible Party: | Ascenta Therapeutics ( Brian Wood, Associate Director, Clinical Development ) |
| Study ID Numbers: | AT-101-CS-204 |
| Study First Received: | October 12, 2007 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00544960 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AT101 AT-101 cancer lung |
non-small cell docetaxel bcl |
|
Thoracic Neoplasms Contraceptive Agents Contraceptive Agents, Female Contraceptive Agents, Male Gossypol acetic acid Gossypol Carcinoma Docetaxel Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Retinol acetate Non-small Cell Lung Cancer Acetic Acid Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Gossypol acetic acid Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antispermatogenic Agents Spermatocidal Agents Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |