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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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)


Further Study Details provided by Ascenta.


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

duration of disease remission

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ascenta Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-204

NCT ID:

NCT00544960

Start Date:

September 2007

Completion Date:

April 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • AT101
  • AT-101
  • cancer
  • lung
  • non-small cell
  • docetaxel
  • bcl
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAsheville, North Carolina