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An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy


Further Study Details provided by Ascenta:


Inclusion Criteria:



- Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed
histology will not be eligible.

- Progression of disease after only one prior platinum containing chemotherapy regimen.
Prior Regimen must not have contained irinotecan

- All patients must have measurable disease.

- 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:

- Patients with more than one prior regimen of chemotherapy or prior regimen that did
not contain a platinum agent. Note: Patient who stopped prior therapy due to
toxicity or had less than 2 cycles of platinum based therapy would not be eligible
for the phase II portion of this study.

- Prior chemotherapy regimen containing irinotecan.

- Active secondary malignancy.

- Unstable or progressive brain metastases.

- Prior history of radiation therapy to > 25% of the bone marrow.

- 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events.

Outcome Time Frame:

13 months

Safety Issue:

Yes

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-101

NCT ID:

NCT00397293

Start Date:

November 2006

Completion Date:

December 2008

Related Keywords:

  • Small Cell Lung Cancer
  • AT101
  • AT-101
  • cancer
  • lung
  • small-cell
  • topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Little Rock, Arkansas  72205-7199
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Charleston, South Carolina  
Lebanon, New Hampshire  
Charleston, West Virginia  25304