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A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT00297089
Collaborator
(none)
165
Enrollment
48
Locations
2
Arms
26
Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT 751 in Combination With Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Pemetrexed + ABT-751

Drug: ABT-751
200 mg ABT-751 daily for 14 days every 21 days

Drug: pemetrexed
Standard pemetrexed every 21 days
Other Names:
  • Alimta

    		•
    Placebo Comparator: B

    Pemetrexed + placebo

    Drug: pemetrexed
    Standard pemetrexed every 21 days
    Other Names:
  • Alimta

    • Drug: placebo
    Placebo daily for 14 days every 21 days

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [Subjects may remain on study until disease progression.]

    Secondary Outcome Measures

    1. Overall Survival [Subjects may remain on study until disease progression.]

    2. Response Rate [Subjects may remain on study until disease progression.]

    3. Time-to-Progression (TTP) [Subjects may remain on study until disease progression.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 0-2

    • 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 than Grade 1 neurological findings

    • Allergy to sulfa medications

    • Previous treatment with ABT-751 or pemetrexed

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 3358 Fayetteville Arkansas United States 72703
    2 Site Reference ID/Investigator# 4102 Hot Springs Arkansas United States 71913
    3 Site Reference ID/Investigator# 2127 Greenbrae California United States 94904
    4 Site Reference ID/Investigator# 2417 Fort Collins Colorado United States 80524
    5 Site Reference ID/Investigator# 5690 Torrington Connecticut United States 06790
    6 Site Reference ID/Investigator# 2411 Fort Lauderdale Florida United States 33316
    7 Site Reference ID/Investigator# 3363 Lakeland Florida United States 33805
    8 Site Reference ID/Investigator# 3352 Port St. Lucie Florida United States 34952
    9 Site Reference ID/Investigator# 3807 Atlanta Georgia United States 30309
    10 Site Reference ID/Investigator# 3353 Chicago Illinois United States 60637
    11 Site Reference ID/Investigator# 3359 Indianapolis Indiana United States 46256
    12 Site Reference ID/Investigator# 2416 Baltimore Maryland United States 21229
    13 Site Reference ID/Investigator# 2244 Baltimore Maryland United States 21231-1000
    14 Site Reference ID/Investigator# 2401 Bethesda Maryland United States 20817
    15 Site Reference ID/Investigator# 3793 Peabody Massachusetts United States 01960
    16 Site Reference ID/Investigator# 3362 Worcester Massachusetts United States 01608
    17 Site Reference ID/Investigator# 2075 Kalamazoo Michigan United States 49048
    18 Site Reference ID/Investigator# 2418 Jefferson City Missouri United States 65109
    19 Site Reference ID/Investigator# 4170 St. Louis Missouri United States 63110-0250
    20 Site Reference ID/Investigator# 3357 Lebanon New Hampshire United States 03756
    21 Site Reference ID/Investigator# 5098 Lake Success New York United States 11042
    22 Site Reference ID/Investigator# 2242 Huntersville North Carolina United States 28078
    23 Site Reference ID/Investigator# 2413 Columbus Ohio United States 43235
    24 Site Reference ID/Investigator# 3354 Bethelem Pennsylvania United States 18015
    25 Site Reference ID/Investigator# 6006 Philadelphia Pennsylvania United States 19141
    26 Site Reference ID/Investigator# 2414 Bristol Tennessee United States 37620
    27 Site Reference ID/Investigator# 2070 Tacoma Washington United States 98405
    28 Site Reference ID/Investigator# 4687 Brno Czech Republic 62500
    29 Site Reference ID/Investigator# 3337 Brno Czech Republic 656 53
    30 Site Reference ID/Investigator# 4278 Kyjov Czech Republic 69733
    31 Site Reference ID/Investigator# 3328 Novy Jicin Czech Republic 741 01
    32 Site Reference ID/Investigator# 3327 Olomouc Czech Republic 775 20
    33 Site Reference ID/Investigator# 3343 Ostrava-Poruba Czech Republic 708 52
    34 Site Reference ID/Investigator# 3344 Prague 2 Czech Republic 128 08
    35 Site Reference ID/Investigator# 3342 Prague 4 Czech Republic 140 59
    36 Site Reference ID/Investigator# 3411 Pribram Czech Republic 262 04
    37 Site Reference ID/Investigator# 3405 Heraklion Greece 71110
    38 Site Reference ID/Investigator# 3403 Thessaloniki Greece 54007
    39 Site Reference ID/Investigator# 3406 Thessaloniki Greece 56403
    40 Site Reference ID/Investigator# 3331 Budapest Hungary H-1529
    41 Site Reference ID/Investigator# 3333 Miskolc Hungary 3529
    42 Site Reference ID/Investigator# 3332 Szekesfehervar Hungary 8000
    43 Site Reference ID/Investigator# 3409 Amsterdam Netherlands 1081 HV
    44 Site Reference ID/Investigator# 3319 Eindhoven Netherlands 5623 EJ
    45 Site Reference ID/Investigator# 3341 Haraderwijk Netherlands 3844 DG
    46 Site Reference ID/Investigator# 3528 Hoorn Netherlands 1624 NP
    47 Site Reference ID/Investigator# 3400 Bratislava Slovakia 826 06
    48 Site Reference ID/Investigator# 3410 Martin Slovakia 036 59

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Gary Gordon, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT00297089
    Other Study ID Numbers:
    • M05-780
    • 2006-002830-38
    First Posted:
    Feb 28, 2006
    Last Update Posted:
    Jan 31, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by AbbVie (prior sponsor, Abbott)
    Lung Cancer
    ABT-751
    NSCLC
    Alimta
    Non-Small-Cell Lung Cancer
    pemetrexed
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Pemetrexed

    Study Results

    No Results Posted as of Jan 31, 2013