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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297089
• Other study ID #: M05-780
• Secondary ID: 2006-002830-38
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 27, 2006
• Last updated: January 29, 2013
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small-Cell Lung Cancer
• NSCLC

Intervention

Drug:
• ABT-751
200 mg ABT-751 daily for 14 days every 21 days
• pemetrexed
Standard pemetrexed every 21 days
• placebo
Placebo daily for 14 days every 21 days

Locations

Country	Name	City	State
Czech Republic	Site Reference ID/Investigator# 3337	Brno
Czech Republic	Site Reference ID/Investigator# 4687	Brno
Czech Republic	Site Reference ID/Investigator# 4278	Kyjov
Czech Republic	Site Reference ID/Investigator# 3328	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 3327	Olomouc
Czech Republic	Site Reference ID/Investigator# 3343	Ostrava-Poruba
Czech Republic	Site Reference ID/Investigator# 3344	Prague 2
Czech Republic	Site Reference ID/Investigator# 3342	Prague 4
Czech Republic	Site Reference ID/Investigator# 3411	Pribram
Greece	Site Reference ID/Investigator# 3405	Heraklion
Greece	Site Reference ID/Investigator# 3403	Thessaloniki
Greece	Site Reference ID/Investigator# 3406	Thessaloniki
Hungary	Site Reference ID/Investigator# 3331	Budapest
Hungary	Site Reference ID/Investigator# 3333	Miskolc
Hungary	Site Reference ID/Investigator# 3332	Szekesfehervar
Netherlands	Site Reference ID/Investigator# 3409	Amsterdam
Netherlands	Site Reference ID/Investigator# 3319	Eindhoven
Netherlands	Site Reference ID/Investigator# 3341	Haraderwijk
Netherlands	Site Reference ID/Investigator# 3528	Hoorn
Slovakia	Site Reference ID/Investigator# 3400	Bratislava
Slovakia	Site Reference ID/Investigator# 3410	Martin
United States	Site Reference ID/Investigator# 3807	Atlanta	Georgia
United States	Site Reference ID/Investigator# 2244	Baltimore	Maryland
United States	Site Reference ID/Investigator# 2416	Baltimore	Maryland
United States	Site Reference ID/Investigator# 3354	Bethelem	Pennsylvania
United States	Site Reference ID/Investigator# 2401	Bethesda	Maryland
United States	Site Reference ID/Investigator# 2414	Bristol	Tennessee
United States	Site Reference ID/Investigator# 3353	Chicago	Illinois
United States	Site Reference ID/Investigator# 2413	Columbus	Ohio
United States	Site Reference ID/Investigator# 3358	Fayetteville	Arkansas
United States	Site Reference ID/Investigator# 2417	Fort Collins	Colorado
United States	Site Reference ID/Investigator# 2411	Fort Lauderdale	Florida
United States	Site Reference ID/Investigator# 2127	Greenbrae	California
United States	Site Reference ID/Investigator# 4102	Hot Springs	Arkansas
United States	Site Reference ID/Investigator# 2242	Huntersville	North Carolina
United States	Site Reference ID/Investigator# 3359	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 2418	Jefferson City	Missouri
United States	Site Reference ID/Investigator# 2075	Kalamazoo	Michigan
United States	Site Reference ID/Investigator# 5098	Lake Success	New York
United States	Site Reference ID/Investigator# 3363	Lakeland	Florida
United States	Site Reference ID/Investigator# 3357	Lebanon	New Hampshire
United States	Site Reference ID/Investigator# 3793	Peabody	Massachusetts
United States	Site Reference ID/Investigator# 6006	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 3352	Port St. Lucie	Florida
United States	Site Reference ID/Investigator# 4170	St. Louis	Missouri
United States	Site Reference ID/Investigator# 2070	Tacoma	Washington
United States	Site Reference ID/Investigator# 5690	Torrington	Connecticut
United States	Site Reference ID/Investigator# 3362	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Czech Republic,  Greece,  Hungary,  Netherlands,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Subjects may remain on study until disease progression.	No
Secondary	Overall Survival		Subjects may remain on study until disease progression.	No
Secondary	Response Rate		Subjects may remain on study until disease progression.	No
Secondary	Time-to-Progression (TTP)		Subjects may remain on study until disease progression.	No