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

NCT00354562 | Terminated Phase 1

• 2 other identifiers: M05-7822006-002838-38
• Study Type: interventional
• Target: 75
• Locations: 4 countries
• Sites: 32

Brief Summary

To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.

Conditions

Lung Cancer; Non-Small Cell Lung Cancer

Keywords

Lung Cancer; Non-Small Cell Lung Cancer; NSCLC; ABT-751; docetaxel; Taxotere

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Subjects may remain on study until disease progression

Secondary Outcomes (3)

• Overall Survival

  Subject may remain on study until disease progression

• Response Rate

  Subject may remain on study until disease progression

• Time-to-Progression (TTP)

  Subject may remain on study until disease progression

Study Arms (2)

A

ACTIVE COMPARATOR

Docetaxel + ABT-751

Drug: ABT-751; Drug: Docetaxel

B

PLACEBO COMPARATOR

Docetaxel + placebo

Drug: Placebo; Drug: Docetaxel

Interventions

ABT-751 DRUG

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

A

Placebo DRUG

Placebo daily for 14 days every 21 days

B

Docetaxel DRUG

Standard Docetaxel every 21 days

Also known as: Taxotere

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent
• 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

You may not qualify if:

• Greater that Grade 1 neurological findings
• Allergy to sulfa medications
• Previous treatment with ABT-751 or docetaxel
• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (32)

Site Ref # / Investigator 3572

Birmingham, Alabama, 35294-3300, United States

Location

Site Ref # / Investigator 4771

Burbank, California, 91505, United States

Location

Site Ref # / Investigator 3574

Orange, California, 92868-3298, United States

Location

Site Ref # / Investigator 3567

Rancho Mirage, California, 92270, United States

Location

Site Ref # / Investigator 3512

Gurnee, Illinois, 60031, United States

Location

Site Ref # / Investigator 3565

Hackensack, New Jersey, 07601, United States

Location

Site Ref # / Investigator 3569

Buffalo, New York, 14215, United States

Location

Site Ref # / Investigator 3511

Cleveland, Ohio, 44195, United States

Location

Site Ref # / Investigator 5237

Ravenna, Ohio, 44266, United States

Location

Site Ref # / Investigator 3551

Crossville, Tennessee, 38555, United States

Location

Site Ref # / Investigator 3549

Knoxville, Tennessee, 37920, United States

Location

Site Ref # / Investigator 3571

Nashville, Tennessee, 37232-6307, United States

Location

Site Ref # / Investigator 3510

Weston, Wisconsin, 54476, United States

Location

Site Ref # / Investigator 3563

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Site Ref # / Investigator 3559

Barrie, Ontario, L4M 6M2, Canada

Location

Site Ref # / Investigator 3561

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Site Ref # / Investigator 3560

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Site Ref # / Investigator 3562

Montreal, Quebec, H2W 1S6, Canada

Location

Site Ref # / Investigator 2222

Montreal, Quebec, H3T 1E2, Canada

Location

Site Ref # / Investigator 3558

Regina, Saskatchewan, S4T 7T1, Canada

Location

Site Ref # / Investigator 5097

Cork, Ireland

Location

Site Ref # / Investigator 4971

Dublin, Ireland

Location

Site Ref # / Investigator 4986

Dublin, Ireland

Location

Site Ref # / Investigator 4999

Dublin, Ireland

Location

Site Ref # / Investigator 5158

Dublin, Ireland

Location

Site Ref # / Investigator 5259

Belfast, BT9 7AB, United Kingdom

Location

Site Ref # / Investigator 5270

East Barming, ME16 9QQ, United Kingdom

Location

Site Ref # / Investigator 5271

Edinburgh, EH42XU, United Kingdom

Location

Site Ref # / Investigator 5017

Glasgow, G12 0YN, United Kingdom

Location

Site Ref # / Investigator 5274

Hull, HU8 9HE, United Kingdom

Location

Site Ref # / Investigator 5273

Surrey, GU2 7XX, United Kingdom

Location

Site Ref # / Investigator 5268

Surrey, SM2 5NG, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

ABT751; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Helen Eliopoulos, MD

  Abbott

  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

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Last Updated: January 7, 2011

Record last verified: 2010-09

Locations

GB (7); IE (5); US (13); CA (7)