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Completed

NCT Number: NCT00297089

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Non-Small-Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site Reference ID/Investigator# 3337, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-751

Drug

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

Pemetrexed

Drug

Standard pemetrexed every 21 days

Other names: Alimta

Placebo

Drug

Placebo daily for 14 days every 21 days

Primary outcomes

  1. Progression-free Survival

    Time frame: Subjects may remain on study until disease progression.

Secondary outcomes

  1. Overall Survival

    Time frame: Subjects may remain on study until disease progression.

  2. Response Rate

    Time frame: Subjects may remain on study until disease progression.

  3. Time-to-Progression (TTP)

    Time frame: Subjects may remain on study until disease progression.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 28, 2006
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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