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A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer


Inclusion Criteria:



- Pathologically documented NSCLC

- Locally advanced (Stage III) or metastatic (Stage IV) NSCLC

- Only one prior anti-tumor treatment regimen in the non-curative setting (i.e.,
2nd-line therapy)

- Only one prior anti-tumor treatment regimen in the curative setting

- Progressive disease following the previous anti-tumor treatment regimen

- Measurable disease by RECIST criteria

- Brain metastasis must be stable and well-controlled

ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to
study entryAll adverse events from prior treatment are resolved or stableAdequate
hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take
adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete
the Quality of Life questionnaireVoluntarily signed informed consent

- Only one prior anti-tumor treatment regimen in the curative setting

- Progressive disease following the previous anti-tumor treatment regimen

- Measurable disease by RECIST criteria

- Brain metastasis must be stable and well-controlled

- ECOG performance score 0-2

- All anti-tumor therapy discontinued at least 3 weeks prior to study entry

- All adverse events from prior treatment are resolved or stable

- Adequate hematologic, renal, and hepatic function

- Females must not be pregnant

- Willing to take adequate measures to prevent pregnancy

- Life expectancy of at least 3 months

- Able to complete the Quality of Life questionnaire

- Voluntarily signed informed consent

Exclusion Criteria:

- Greater that Grade 1 neurological findings

- Allergy to sulfa medications

- Previous treatment with ABT-751 or docetaxel

- Receipt of more than one investigational agent for NSCLC

- Significant weight loss (>10%) within 6 weeks of study entry

- Glucose-6-phosphate dehydrogenase deficiency or porphyria

- Significant systemic disease that would adversely affect participation

- Class 3-4 New York Heart Association classification status

- Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin
cancer, or any other cancer considered adequately treated and cured by the
investigator

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

Subjects may remain on study until disease progression

Safety Issue:

No

Principal Investigator

Helen Eliopoulos, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M05-782

NCT ID:

NCT00354562

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLC
  • ABT-751
  • docetaxel
  • Taxotere
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Site Ref # / Investigator 3572Birmingham, Alabama  35294-3300
Site Ref # / Investigator 4771Burbank, California  91505
Site Ref # / Investigator 3574Orange, California  92868-3298
Site Ref # / Investigator 3567Rancho Mirage, California  92270
Site Ref # / Investigator 3512Gurnee, Illinois  60031
Site Ref # / Investigator 3565Hackensack, New Jersey  07601
Site Ref # / Investigator 3569Buffalo, New York  14215
Site Ref # / Investigator 3511Cleveland, Ohio  44195
Site Ref # / Investigator 5237Ravenna, Ohio  44266
Site Ref # / Investigator 3551Crossville, Tennessee  38555
Site Ref # / Investigator 3549Knoxville, Tennessee  37920
Site Ref # / Investigator 3571Nashville, Tennessee  37232-6307
Site Ref # / Investigator 3510Weston, Wisconsin  54476