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

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: AT-101 and docetaxel (Drug); placebo and docetaxel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ascenta Therapeutics

Official(s) and/or principal investigator(s):
Lance Leopold, MD, Study Chair, Affiliation: Ascenta Therapeutics, Inc.

Overall contact:
Brian Wood, Phone: 610-725-1505

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

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)

Study design: Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Primary outcome: To estimate and compare the progression free survival (PFS) of AT-101 in combination with docetaxel with docetaxel and placebo

Secondary outcome: Safety of AT-101 in combination with docetaxel and secondary efficacy measures

Detailed description: Further Study Details provided by Ascenta.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Brian Wood, Phone: 610-725-1505

Research Site, Arkhangelsk, Russian Federation; Active, not recruiting

Research Site, Chelyabinsk, Russian Federation; Active, not recruiting

Research Site, Ekaterinburg, Russian Federation; Active, not recruiting

Research Site, Kaliningrad, Russian Federation; Active, not recruiting

Research Site, Kazan, Russian Federation; Active, not recruiting

Research Site, Moscow, Russian Federation; Active, not recruiting

Research Sites (4), Saint Petersburg, Russian Federation; Active, not recruiting

Research Site, Samara, Russian Federation; Active, not recruiting

Research Site, Stavropol, Russian Federation; Active, not recruiting

Research Site, Voronezh, Russian Federation; Active, not recruiting

Research Site, Dnipropetrovsk, Ukraine; Active, not recruiting

Research Site, Donetsk, Ukraine; Active, not recruiting

Research Site, Lugansk, Ukraine; Active, not recruiting

Research Site, Kyiv, Ukraine; Active, not recruiting

Research Site, Kharkiv, Ukraine; Active, not recruiting

Research Site, Uzhgorod, Ukraine; Active, not recruiting

Research Site, Zaporizhzhya, Ukraine; Active, not recruiting

Research Site, Durham, North Carolina, United States; Recruiting

Starting date: September 2007
Ending date: March 2009
Last updated: June 3, 2008