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| Sponsor: | 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: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
| Enrollment: | 106 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
|
Placebo Comparator: 2
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 | |
| Kaliningrad, Russian Federation | |
| Research Site | |
| Kazan, Russian Federation | |
| Research Site | |
| Moscow, Russian Federation | |
| Research Sites (4) | |
| Saint Petersburg, Russian Federation | |
| Research Site | |
| Samara, Russian Federation | |
| Research Site | |
| Stavropol, Russian Federation | |
| Research Site | |
| Voronezh, Russian Federation | |
| Ukraine | |
| Research Site | |
| Dnipropetrovsk, Ukraine | |
| Research Site | |
| Donetsk, Ukraine | |
| Research Site | |
| Kharkiv, Ukraine | |
| Research Site | |
| Kyiv, Ukraine | |
| Research Site | |
| Lugansk, Ukraine | |
| Research Site | |
| Uzhgorod, Ukraine | |
| Research Site | |
| Zaporizhzhya, Ukraine | |
| Study Chair: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
| Responsible Party: | Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00544960 History of Changes |
| Other Study ID Numbers: | AT-101-CS-204 |
| Study First Received: | October 12, 2007 |
| Last Updated: | August 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
AT101 AT-101 cancer lung |
non-small cell docetaxel bcl |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gossypol Gossypol acetic acid |
Docetaxel Contraceptive Agents, Male Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Phytogenic Antineoplastic Agents Contraceptive Agents, Female Spermatocidal Agents Antispermatogenic Agents |