A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00544960

Run by

Ascenta Therapeutics

People needed

106

Starts

2007-09-01

Expected to finish

2009-04-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Research Site — Durham, North Carolina, United States
• Research Site — Arkhangelsk, Russia
• Research Site — Chelyabinsk, Russia
• Research Site — Kaliningrad, Russia
• Research Site — Kazan', Russia
• Research Site — Moscow, Russia
• Research Sites (4) — Saint Petersburg, Russia
• Research Site — Samara, Russia
• Research Site — Stavropol, Russia
• Research Site — Voronezh, Russia
• Research Site — Yekaterinburg, Russia
• Research Site — Dnipropetrovsk, Ukraine
• Research Site — Donetsk, Ukraine
• Research Site — Kharkiv, Ukraine
• Research Site — Kyiv, Ukraine
• Research Site — Luhansk, Ukraine
• Research Site — Uzhhorod, Ukraine
• Research Site — Zaporizhzhya, Ukraine

Full record on ClinicalTrials.gov

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