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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Non-Small Cell Lung Cancer

Intervention: ABT-751 (Drug); Placebo (Drug); Docetaxel (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Helen Eliopoulos, MD, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

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

Primary outcome: Progression-free Survival

Secondary outcome:

Overall Survival

Response Rate

Time-to-Progression (TTP)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 0-2All 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

- 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 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

Locations and Contacts

Site Ref # / Investigator 5097, Cork, Ireland

Site Ref # / Investigator 4986, Dublin 24, Ireland

Site Ref # / Investigator 4999, Dublin 4, Ireland

Site Ref # / Investigator 5158, Dublin 7, Ireland

Site Ref # / Investigator 4971, Dublin 8, Ireland

Site Ref # / Investigator 5270, Barming ME16 9QQ, United Kingdom

Site Ref # / Investigator 5259, Belfast BT9 7AB, United Kingdom

Site Ref # / Investigator 5271, Edinburgh EH42XU, United Kingdom

Site Ref # / Investigator 5017, Glasgow G12 0YN, United Kingdom

Site Ref # / Investigator 5274, Hull HU8 9HE, United Kingdom

Site Ref # / Investigator 5268, Surrey SM2 5NG, United Kingdom

Site Ref # / Investigator 5273, Surrey GU2 7XX, United Kingdom

Site Ref # / Investigator 3572, Birmingham, Alabama 35294-3300, United States

Site Ref # / Investigator 4771, Burbank, California 91505, United States

Site Ref # / Investigator 3574, Orange, California 92868-3298, United States

Site Ref # / Investigator 3567, Rancho Mirage, California 92270, United States

Site Ref # / Investigator 3512, Gurnee, Illinois 60031, United States

Site Ref # / Investigator 3565, Hackensack, New Jersey 07601, United States

Site Ref # / Investigator 3569, Buffalo, New York 14215, United States

Site Ref # / Investigator 3563, Sydney, Nova Scotia B1P 1P3, Canada

Site Ref # / Investigator 3511, Cleveland, Ohio 44195, United States

Site Ref # / Investigator 5237, Ravenna, Ohio 44266, United States

Site Ref # / Investigator 3559, Barrie, Ontario L4M 6M2, Canada

Site Ref # / Investigator 3561, Sudbury, Ontario P3E 5J1, Canada

Site Ref # / Investigator 3560, Greenfield Park, Quebec J4V 2H1, Canada

Site Ref # / Investigator 2222, Montreal, Quebec H3T 1E2, Canada

Site Ref # / Investigator 3562, Montreal, Quebec H2W 1S6, Canada

Site Ref # / Investigator 3558, Regina, Saskatchewan S4T 7T1, Canada

Site Ref # / Investigator 3551, Crossville, Tennessee 38555, United States

Site Ref # / Investigator 3549, Knoxville, Tennessee 37920, United States

Site Ref # / Investigator 3571, Nashville, Tennessee 37232-6307, United States

Site Ref # / Investigator 3510, Weston, Wisconsin 54476, United States

Additional Information

Starting date: February 2007
Last updated: January 5, 2011

Page last updated: August 23, 2015

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