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

Primary Purpose

Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABT-751
pemetrexed
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 3358
  • Site Reference ID/Investigator# 4102
  • Site Reference ID/Investigator# 2127
  • Site Reference ID/Investigator# 2417
  • Site Reference ID/Investigator# 5690
  • Site Reference ID/Investigator# 2411
  • Site Reference ID/Investigator# 3363
  • Site Reference ID/Investigator# 3352
  • Site Reference ID/Investigator# 3807
  • Site Reference ID/Investigator# 3353
  • Site Reference ID/Investigator# 3359
  • Site Reference ID/Investigator# 2416
  • Site Reference ID/Investigator# 2244
  • Site Reference ID/Investigator# 2401
  • Site Reference ID/Investigator# 3793
  • Site Reference ID/Investigator# 3362
  • Site Reference ID/Investigator# 2075
  • Site Reference ID/Investigator# 2418
  • Site Reference ID/Investigator# 4170
  • Site Reference ID/Investigator# 3357
  • Site Reference ID/Investigator# 5098
  • Site Reference ID/Investigator# 2242
  • Site Reference ID/Investigator# 2413
  • Site Reference ID/Investigator# 3354
  • Site Reference ID/Investigator# 6006
  • Site Reference ID/Investigator# 2414
  • Site Reference ID/Investigator# 2070
  • Site Reference ID/Investigator# 4687
  • Site Reference ID/Investigator# 3337
  • Site Reference ID/Investigator# 4278
  • Site Reference ID/Investigator# 3328
  • Site Reference ID/Investigator# 3327
  • Site Reference ID/Investigator# 3343
  • Site Reference ID/Investigator# 3344
  • Site Reference ID/Investigator# 3342
  • Site Reference ID/Investigator# 3411
  • Site Reference ID/Investigator# 3405
  • Site Reference ID/Investigator# 3403
  • Site Reference ID/Investigator# 3406
  • Site Reference ID/Investigator# 3331
  • Site Reference ID/Investigator# 3333
  • Site Reference ID/Investigator# 3332
  • Site Reference ID/Investigator# 3409
  • Site Reference ID/Investigator# 3319
  • Site Reference ID/Investigator# 3341
  • Site Reference ID/Investigator# 3528
  • Site Reference ID/Investigator# 3400
  • Site Reference ID/Investigator# 3410

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Pemetrexed + ABT-751

Pemetrexed + placebo

Outcomes

Primary Outcome Measures

Progression-free Survival

Secondary Outcome Measures

Overall Survival
Response Rate
Time-to-Progression (TTP)

Full Information

First Posted
February 27, 2006
Last Updated
January 29, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00297089
Brief Title
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer
Keywords
Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Pemetrexed + ABT-751
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Pemetrexed + placebo
Intervention Type
Drug
Intervention Name(s)
ABT-751
Intervention Description
200 mg ABT-751 daily for 14 days every 21 days
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Standard pemetrexed every 21 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo daily for 14 days every 21 days
Primary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
Subjects may remain on study until disease progression.
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Subjects may remain on study until disease progression.
Title
Response Rate
Time Frame
Subjects may remain on study until disease progression.
Title
Time-to-Progression (TTP)
Time Frame
Subjects may remain on study until disease progression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Gordon, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 3358
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Site Reference ID/Investigator# 4102
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Site Reference ID/Investigator# 2127
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Site Reference ID/Investigator# 2417
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Site Reference ID/Investigator# 5690
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Site Reference ID/Investigator# 2411
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Site Reference ID/Investigator# 3363
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Site Reference ID/Investigator# 3352
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Site Reference ID/Investigator# 3807
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Site Reference ID/Investigator# 3353
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Site Reference ID/Investigator# 3359
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Site Reference ID/Investigator# 2416
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Site Reference ID/Investigator# 2244
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Site Reference ID/Investigator# 2401
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Site Reference ID/Investigator# 3793
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Site Reference ID/Investigator# 3362
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Site Reference ID/Investigator# 2075
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Site Reference ID/Investigator# 2418
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Site Reference ID/Investigator# 4170
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Site Reference ID/Investigator# 3357
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Site Reference ID/Investigator# 5098
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site Reference ID/Investigator# 2242
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Site Reference ID/Investigator# 2413
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Site Reference ID/Investigator# 3354
City
Bethelem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Site Reference ID/Investigator# 6006
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Site Reference ID/Investigator# 2414
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Site Reference ID/Investigator# 2070
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Site Reference ID/Investigator# 4687
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3337
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 4278
City
Kyjov
ZIP/Postal Code
69733
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3328
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3327
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3343
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3344
City
Prague 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3342
City
Prague 4
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3411
City
Pribram
ZIP/Postal Code
262 04
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 3405
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Site Reference ID/Investigator# 3403
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
Site Reference ID/Investigator# 3406
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Site Reference ID/Investigator# 3331
City
Budapest
ZIP/Postal Code
H-1529
Country
Hungary
Facility Name
Site Reference ID/Investigator# 3333
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Site Reference ID/Investigator# 3332
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Site Reference ID/Investigator# 3409
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 3319
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 3341
City
Haraderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 3528
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 3400
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Site Reference ID/Investigator# 3410
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21300929
Citation
Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. doi: 10.1200/JCO.2010.32.5944. Epub 2011 Feb 7.
Results Reference
derived

Learn more about this trial

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

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