Clinical trial NCT00397293: Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Keywords: AT101
AT-101
cancer
lung
small-cell
topotecan
Lead sponsor: Ascenta Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer

Detailed description: Further Study Details provided by Ascenta:

Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants with adverse events.
timeFrame: 13 months
Secondary outcomes:
measure: complete or partial remission of disease
timeFrame: 16 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Loma Linda
country: United States
state: California
city: Stamford
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Lake City
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Lebanon
country: United States
state: New Hampshire
city: High Point
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Columbia
country: United States
state: South Carolina
city: Hilton Head Island
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Huntington
country: United States
state: West Virginia
city: Russia
country: Russian Federation
facility: Research Center (16)
city: Ukraine
country: Ukraine
facility: Research Centers (8)
Study officials:
affiliation: Ascenta Therapeutics, Inc.
name: Lance Leopold, MD
role: STUDY_CHAIR
References: