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

January 29, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 62500
        • Site Reference ID/Investigator# 4687
      • Brno, Czech Republic, 656 53
        • Site Reference ID/Investigator# 3337
      • Kyjov, Czech Republic, 69733
        • Site Reference ID/Investigator# 4278
      • Novy Jicin, Czech Republic, 741 01
        • Site Reference ID/Investigator# 3328
      • Olomouc, Czech Republic, 775 20
        • Site Reference ID/Investigator# 3327
      • Ostrava-Poruba, Czech Republic, 708 52
        • Site Reference ID/Investigator# 3343
      • Prague 2, Czech Republic, 128 08
        • Site Reference ID/Investigator# 3344
      • Prague 4, Czech Republic, 140 59
        • Site Reference ID/Investigator# 3342
      • Pribram, Czech Republic, 262 04
        • Site Reference ID/Investigator# 3411
  • Greece
      • Heraklion, Greece, 71110
        • Site Reference ID/Investigator# 3405
      • Thessaloniki, Greece, 54007
        • Site Reference ID/Investigator# 3403
      • Thessaloniki, Greece, 56403
        • Site Reference ID/Investigator# 3406
  • Hungary
      • Budapest, Hungary, H-1529
        • Site Reference ID/Investigator# 3331
      • Miskolc, Hungary, 3529
        • Site Reference ID/Investigator# 3333
      • Szekesfehervar, Hungary, 8000
        • Site Reference ID/Investigator# 3332
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Site Reference ID/Investigator# 3409
      • Eindhoven, Netherlands, 5623 EJ
        • Site Reference ID/Investigator# 3319
      • Haraderwijk, Netherlands, 3844 DG
        • Site Reference ID/Investigator# 3341
      • Hoorn, Netherlands, 1624 NP
        • Site Reference ID/Investigator# 3528
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Site Reference ID/Investigator# 3400
      • Martin, Slovakia, 036 59
        • Site Reference ID/Investigator# 3410
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Site Reference ID/Investigator# 3358
      • Hot Springs, Arkansas, United States, 71913
        • Site Reference ID/Investigator# 4102
    • California
      • Greenbrae, California, United States, 94904
        • Site Reference ID/Investigator# 2127
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • Site Reference ID/Investigator# 2417
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Site Reference ID/Investigator# 5690
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Site Reference ID/Investigator# 2411
      • Lakeland, Florida, United States, 33805
        • Site Reference ID/Investigator# 3363
      • Port St. Lucie, Florida, United States, 34952
        • Site Reference ID/Investigator# 3352
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Site Reference ID/Investigator# 3807
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator# 3353
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Site Reference ID/Investigator# 3359
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Site Reference ID/Investigator# 2416
      • Baltimore, Maryland, United States, 21231-1000
        • Site Reference ID/Investigator# 2244
      • Bethesda, Maryland, United States, 20817
        • Site Reference ID/Investigator# 2401
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Site Reference ID/Investigator# 3793
      • Worcester, Massachusetts, United States, 01608
        • Site Reference ID/Investigator# 3362
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Site Reference ID/Investigator# 2075
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Site Reference ID/Investigator# 2418
      • St. Louis, Missouri, United States, 63110-0250
        • Site Reference ID/Investigator# 4170
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Site Reference ID/Investigator# 3357
    • New York
      • Lake Success, New York, United States, 11042
        • Site Reference ID/Investigator# 5098
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Site Reference ID/Investigator# 2242
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Site Reference ID/Investigator# 2413
    • Pennsylvania
      • Bethelem, Pennsylvania, United States, 18015
        • Site Reference ID/Investigator# 3354
      • Philadelphia, Pennsylvania, United States, 19141
        • Site Reference ID/Investigator# 6006
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Site Reference ID/Investigator# 2414
    • Washington
      • Tacoma, Washington, United States, 98405
        • Site Reference ID/Investigator# 2070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 0-2
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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: Subjects may remain on study until disease progression.
Subjects may remain on study until disease progression.
Response Rate
Time Frame: Subjects may remain on study until disease progression.
Subjects may remain on study until disease progression.
Time-to-Progression (TTP)
Time Frame: Subjects may remain on study until disease progression.
Subjects may remain on study until disease progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (ESTIMATE)

February 28, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-780
  • 2006-002830-38 (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.

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