NCT00544960

Brief Summary

This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

Trial Health

90
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
3 countries

18 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

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 27, 2010

Status Verified

August 1, 2010

Enrollment Period

1.2 years

First QC Date

October 12, 2007

Last Update Submit

August 24, 2010

Conditions

Non-small Cell Lung Cancer

Keywords

AT101AT-101cancerlungnon-small celldocetaxelbcl

Outcome Measures

Primary Outcomes (1)

  • duration of disease remission

    12 months

Secondary Outcomes (1)

  • number of participants with adverse events

    12 months

Study Arms (2)

1

EXPERIMENTAL

AT-101 and docetaxel

Drug: AT-101 and docetaxel

2

PLACEBO COMPARATOR

placebo and docetaxel

Drug: placebo and docetaxel

Interventions

AT-101 and docetaxelDRUG

AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops

1
placebo and docetaxelDRUG

placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops

2

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
  • Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
  • All patients must have measurable disease.
  • No unstable or progressive brain metastases.
  • 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:

  • Prior chemotherapy regimen containing docetaxel.
  • Active secondary malignancy.
  • 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 (18)

Research Site

Durham, North Carolina, United States

Location

Research Site

Arkhangelsk, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Kaliningrad, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Sites (4)

Saint Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Stavropol, Russia

Location

Research Site

Voronezh, Russia

Location

Research Site

Yekaterinburg, Russia

Location

Research Site

Dnipropetrovsk, Ukraine

Location

Research Site

Donetsk, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Kyiv, Ukraine

Location

Research Site

Luhansk, Ukraine

Location

Research Site

Uzhhorod, Ukraine

Location

Research Site

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasms

Interventions

gossypol acetic acidDocetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Lance Leopold, MD

    Ascenta Therapeutics, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2008

Study Completion

April 1, 2009

Last Updated

August 27, 2010

Record last verified: 2010-08

Locations

RU(10)US(1)UA(7)