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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397293
• Other study ID #: AT-101-CS-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 7, 2006
• Last updated: August 20, 2010
• Start date: November 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2010
• Source: Ascenta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Further Study Details provided by Ascenta:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• AT-101
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
• topotecan
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
Russian Federation	Research Center (16)	Russia
Ukraine	Research Centers (8)	Ukraine

Sponsors (1)

Lead Sponsor	Collaborator
Ascenta Therapeutics

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events.		13 months	Yes
Secondary	complete or partial remission of disease		16 months	No