- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354562
A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Sydney, Nova Scotia, Canada, B1P 1P3
- Site Ref # / Investigator 3563
-
-
Ontario
-
Barrie, Ontario, Canada, L4M 6M2
- Site Ref # / Investigator 3559
-
Sudbury, Ontario, Canada, P3E 5J1
- Site Ref # / Investigator 3561
-
-
Quebec
-
Greenfield Park, Quebec, Canada, J4V 2H1
- Site Ref # / Investigator 3560
-
Montreal, Quebec, Canada, H2W 1S6
- Site Ref # / Investigator 3562
-
Montreal, Quebec, Canada, H3T 1E2
- Site Ref # / Investigator 2222
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Site Ref # / Investigator 3558
-
-
-
-
-
Cork, Ireland
- Site Ref # / Investigator 5097
-
Dublin 24, Ireland
- Site Ref # / Investigator 4986
-
Dublin 4, Ireland
- Site Ref # / Investigator 4999
-
Dublin 7, Ireland
- Site Ref # / Investigator 5158
-
Dublin 8, Ireland
- Site Ref # / Investigator 4971
-
-
-
-
-
Barming, United Kingdom, ME16 9QQ
- Site Ref # / Investigator 5270
-
Belfast, United Kingdom, BT9 7AB
- Site Ref # / Investigator 5259
-
Edinburgh, United Kingdom, EH42XU
- Site Ref # / Investigator 5271
-
Glasgow, United Kingdom, G12 0YN
- Site Ref # / Investigator 5017
-
Hull, United Kingdom, HU8 9HE
- Site Ref # / Investigator 5274
-
Surrey, United Kingdom, GU2 7XX
- Site Ref # / Investigator 5273
-
Surrey, United Kingdom, SM2 5NG
- Site Ref # / Investigator 5268
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294-3300
- Site Ref # / Investigator 3572
-
-
California
-
Burbank, California, United States, 91505
- Site Ref # / Investigator 4771
-
Orange, California, United States, 92868-3298
- Site Ref # / Investigator 3574
-
Rancho Mirage, California, United States, 92270
- Site Ref # / Investigator 3567
-
-
Illinois
-
Gurnee, Illinois, United States, 60031
- Site Ref # / Investigator 3512
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Site Ref # / Investigator 3565
-
-
New York
-
Buffalo, New York, United States, 14215
- Site Ref # / Investigator 3569
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Site Ref # / Investigator 3511
-
Ravenna, Ohio, United States, 44266
- Site Ref # / Investigator 5237
-
-
Tennessee
-
Crossville, Tennessee, United States, 38555
- Site Ref # / Investigator 3551
-
Knoxville, Tennessee, United States, 37920
- Site Ref # / Investigator 3549
-
Nashville, Tennessee, United States, 37232-6307
- Site Ref # / Investigator 3571
-
-
Wisconsin
-
Weston, Wisconsin, United States, 54476
- Site Ref # / Investigator 3510
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: A
Docetaxel + ABT-751
|
200mg ABT-751 daily for 14 days every 21 days
Standard Docetaxel every 21 days
Other Names:
|
PLACEBO_COMPARATOR: B
Docetaxel + placebo
|
Standard Docetaxel every 21 days
Other Names:
Placebo daily for 14 days every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival
Time Frame: Subjects may remain on study until disease progression
|
Subjects may remain on study until disease progression
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: Subject may remain on study until disease progression
|
Subject may remain on study until disease progression
|
Response Rate
Time Frame: Subject may remain on study until disease progression
|
Subject may remain on study until disease progression
|
Time-to-Progression (TTP)
Time Frame: Subject may remain on study until disease progression
|
Subject may remain on study until disease progression
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- M05-782
- 2006-002838-38 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on ABT-751
-
M.D. Anderson Cancer CenterCompletedHematological MalignanciesUnited States
-
AbbottCompleted
-
AbbottCompleted
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone TherapyProstate CancerUnited States
-
National Institutes of Health Clinical Center (CC)National Cancer Institute (NCI)CompletedSarcoma | Kidney Cancer | Unspecified Childhood Solid Tumor, Protocol Specific | Ovarian Cancer | Brain and Central Nervous System Tumors | Neuroblastoma | Liver Cancer | Extragonadal Germ Cell Tumor | Childhood Germ Cell TumorUnited States
-
AbbottCompletedNon-Small Cell Lung CancerUnited States
-
AbbottCompletedBreast CancerUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Disseminated NeuroblastomaUnited States, Canada
-
Konstantin DragnevAbbottTerminatedLung Cancer | Non Small Cell Lung CancerUnited States
-
Cerevel Therapeutics, LLCCompleted