Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

Sponsor

Ascenta Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00397293

Collaborator

(none)

Enrollment

Locations

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: AT-101 Drug: topotecan	Phase 1/Phase 2

Detailed Description

Further Study Details provided by Ascenta:

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events. [13 months]

Secondary Outcome Measures

complete or partial remission of disease [16 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35233
2		Hot Springs	Arkansas	United States
3		Loma Linda	California	United States	92354
4		Stamford	Connecticut	United States
5		Jacksonville	Florida	United States
6		Lake City	Florida	United States
7		Boston	Massachusetts	United States	02114
8		Rochester	Minnesota	United States	55905
9		Lebanon	New Hampshire	United States
10		High Point	North Carolina	United States
11		Portland	Oregon	United States	97213
12		Columbia	South Carolina	United States
13		Hilton Head Island	South Carolina	United States
14		Germantown	Tennessee	United States
15		Austin	Texas	United States	78705
16		Burlington	Vermont	United States	05405
17		Huntington	West Virginia	United States
18	Research Center (16)	Russia		Russian Federation
19	Research Centers (8)	Ukraine		Ukraine