NCT00397293

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Geographic Reach
3 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

2.1 years

First QC Date

November 7, 2006

Last Update Submit

August 20, 2010

Conditions

Small Cell Lung Cancer

Keywords

AT101AT-101cancerlungsmall-celltopotecan

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events.

    13 months

Secondary Outcomes (1)

  • complete or partial remission of disease

    16 months

Interventions

AT-101DRUG

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.

topotecanDRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Birmingham, Alabama, 35233, United States

Location

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Loma Linda, California, 92354, United States

Location

Unknown Facility

Stamford, Connecticut, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Lake City, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Portland, Oregon, 97213, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Hilton Head Island, South Carolina, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Burlington, Vermont, 05405, United States

Location

Unknown Facility

Huntington, West Virginia, United States

Location

Research Center (16)

Russia, Russia, Russia

Location

Research Centers (8)

Ukraine, Ukraine, Ukraine

Location

MeSH Terms

Conditions

Small Cell Lung CarcinomaNeoplasms

Interventions

gossypol acetic acidTopotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Lance Leopold, MD

    Ascenta Therapeutics, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(17)UA(1)RU(1)