NCT00297089

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
6 countries

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

February 27, 2006

Last Update Submit

January 29, 2013

Conditions

Lung CancerNSCLCNon-Small-Cell Lung Cancer

Keywords

Lung CancerABT-751NSCLCAlimtaNon-Small-Cell Lung Cancerpemetrexed

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    Subjects may remain on study until disease progression.

Secondary Outcomes (3)

  • Overall Survival

    Subjects may remain on study until disease progression.

  • Response Rate

    Subjects may remain on study until disease progression.

  • Time-to-Progression (TTP)

    Subjects may remain on study until disease progression.

Study Arms (2)

A

ACTIVE COMPARATOR

Pemetrexed + ABT-751

Drug: ABT-751Drug: pemetrexed

B

PLACEBO COMPARATOR

Pemetrexed + placebo

Drug: pemetrexedDrug: placebo

Interventions

ABT-751DRUG

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

A
pemetrexedDRUG

Standard pemetrexed every 21 days

Also known as: Alimta
AB
placeboDRUG

Placebo daily for 14 days every 21 days

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Site Reference ID/Investigator# 3358

Fayetteville, Arkansas, 72703, United States

Location

Site Reference ID/Investigator# 4102

Hot Springs, Arkansas, 71913, United States

Location

Site Reference ID/Investigator# 2127

Greenbrae, California, 94904, United States

Location

Site Reference ID/Investigator# 2417

Fort Collins, Colorado, 80524, United States

Location

Site Reference ID/Investigator# 5690

Torrington, Connecticut, 06790, United States

Location

Site Reference ID/Investigator# 2411

Fort Lauderdale, Florida, 33316, United States

Location

Site Reference ID/Investigator# 3363

Lakeland, Florida, 33805, United States

Location

Site Reference ID/Investigator# 3352

Port Saint Lucie, Florida, 34952, United States

Location

Site Reference ID/Investigator# 3807

Atlanta, Georgia, 30309, United States

Location

Site Reference ID/Investigator# 3353

Chicago, Illinois, 60637, United States

Location

Site Reference ID/Investigator# 3359

Indianapolis, Indiana, 46256, United States

Location

Site Reference ID/Investigator# 2416

Baltimore, Maryland, 21229, United States

Location

Site Reference ID/Investigator# 2244

Baltimore, Maryland, 21231-1000, United States

Location

Site Reference ID/Investigator# 2401

Bethesda, Maryland, 20817, United States

Location

Site Reference ID/Investigator# 3793

Peabody, Massachusetts, 01960, United States

Location

Site Reference ID/Investigator# 3362

Worcester, Massachusetts, 01608, United States

Location

Site Reference ID/Investigator# 2075

Kalamazoo, Michigan, 49048, United States

Location

Site Reference ID/Investigator# 2418

Jefferson City, Missouri, 65109, United States

Location

Site Reference ID/Investigator# 4170

St Louis, Missouri, 63110-0250, United States

Location

Site Reference ID/Investigator# 3357

Lebanon, New Hampshire, 03756, United States

Location

Site Reference ID/Investigator# 5098

Lake Success, New York, 11042, United States

Location

Site Reference ID/Investigator# 2242

Huntersville, North Carolina, 28078, United States

Location

Site Reference ID/Investigator# 2413

Columbus, Ohio, 43235, United States

Location

Site Reference ID/Investigator# 3354

Bethelem, Pennsylvania, 18015, United States

Location

Site Reference ID/Investigator# 6006

Philadelphia, Pennsylvania, 19141, United States

Location

Site Reference ID/Investigator# 2414

Bristol, Tennessee, 37620, United States

Location

Site Reference ID/Investigator# 2070

Tacoma, Washington, 98405, United States

Location

Site Reference ID/Investigator# 4687

Brno, 62500, Czechia

Location

Site Reference ID/Investigator# 3337

Brno, 656 53, Czechia

Location

Site Reference ID/Investigator# 4278

Kyjov, 69733, Czechia

Location

Site Reference ID/Investigator# 3328

Nový Jičín, 741 01, Czechia

Location

Site Reference ID/Investigator# 3327

Olomouc, 775 20, Czechia

Location

Site Reference ID/Investigator# 3343

Ostrava-Poruba, 708 52, Czechia

Location

Site Reference ID/Investigator# 3344

Prague, 128 08, Czechia

Location

Site Reference ID/Investigator# 3342

Prague, 140 59, Czechia

Location

Site Reference ID/Investigator# 3411

Příbram, 262 04, Czechia

Location

Site Reference ID/Investigator# 3405

Heraklion, 71110, Greece

Location

Site Reference ID/Investigator# 3403

Thessaloniki, 54007, Greece

Location

Site Reference ID/Investigator# 3406

Thessaloniki, 56403, Greece

Location

Site Reference ID/Investigator# 3331

Budapest, H-1529, Hungary

Location

Site Reference ID/Investigator# 3333

Miskolc, 3529, Hungary

Location

Site Reference ID/Investigator# 3332

Székesfehérvár, 8000, Hungary

Location

Site Reference ID/Investigator# 3409

Amsterdam, 1081 HV, Netherlands

Location

Site Reference ID/Investigator# 3319

Eindhoven, 5623 EJ, Netherlands

Location

Site Reference ID/Investigator# 3341

Haraderwijk, 3844 DG, Netherlands

Location

Site Reference ID/Investigator# 3528

Hoorn, 1624 NP, Netherlands

Location

Site Reference ID/Investigator# 3400

Bratislava, 826 06, Slovakia

Location

Site Reference ID/Investigator# 3410

Martin, 036 59, Slovakia

Location

Related Publications (1)

  • 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.

    PMID: 21300929DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

ABT751Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Gary Gordon, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

HU(3)SL(2)NL(4)CZ(9)GR(3)US(27)