| October 12, 2007 |
| July 16, 2009 |
| September 2007 |
| November 2008 (final data collection date for primary outcome measure) |
| To estimate and compare the progression free survival (PFS) of AT-101 in combination with docetaxel with docetaxel and placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| To estimate and compare the progression free survival (PFS) of AT-101 in combination with docetaxel with docetaxel and placebo |
| Complete list of historical versions of study NCT00544960 on ClinicalTrials.gov Archive Site |
| Safety of AT-101 in combination with docetaxel and secondary efficacy measures [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Safety of AT-101 in combination with docetaxel and secondary efficacy measures |
| |
| A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer |
| 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) |
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 |
Further Study Details provided by Ascenta. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment |
| Non-small Cell Lung Cancer |
- Drug: AT-101 and docetaxel
- Drug: placebo and docetaxel
|
- Experimental: AT-101 and docetaxel
- Placebo Comparator: placebo and docetaxel
|
| |
| |
| Active, not recruiting |
| 102 |
| April 2009 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
- Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- All patients must have measurable disease.
- No unstable or progressive brain metastases.
- Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
- ECOG performance status 0-1
- Adequate hematologic function
- Adequate liver and renal function
- Ability to swallow oral medication
Exclusion Criteria:
- Prior chemotherapy regimen containing docetaxel.
- Active secondary malignancy.
- Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Russian Federation, Ukraine |
| |
| NCT00544960 |
| Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics |
| AT-101-CS-204 |
| Ascenta Therapeutics |
|
| Study Chair: |
Lance Leopold, MD |
Ascenta Therapeutics, Inc. |
|
|
| Ascenta Therapeutics |
| July 2009 |