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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00297089
First received: February 27, 2006
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
NSCLC
Non-Small-Cell Lung Cancer
Drug: ABT-751
Drug: pemetrexed
Drug: placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]
  • Time-to-Progression (TTP) [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: November 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Pemetrexed + ABT-751
Drug: ABT-751
200 mg ABT-751 daily for 14 days every 21 days
Drug: pemetrexed
Standard pemetrexed every 21 days
Other Name: Alimta
Placebo Comparator: B
Pemetrexed + placebo
Drug: pemetrexed
Standard pemetrexed every 21 days
Other Name: Alimta
Drug: placebo
Placebo daily for 14 days every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 0-2
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297089

  Show 48 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Gary Gordon, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00297089     History of Changes
Other Study ID Numbers: M05-780, 2006-002830-38
Study First Received: February 27, 2006
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Lung Cancer
ABT-751
NSCLC
Alimta
Non-Small-Cell Lung Cancer
pemetrexed

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014