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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00297089

Enrollment

165

Registered

2006-02-28

Start date

2006-11-30

Completion date

2009-01-31

Last updated

2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer

Keywords

Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed

Brief 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.

Interventions

DRUGABT-751

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

DRUGpemetrexed

Standard pemetrexed every 21 days

DRUGplacebo

Placebo daily for 14 days every 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free Survival	Subjects may remain on study until disease progression.

Secondary

Measure	Time frame
Overall Survival	Subjects may remain on study until disease progression.
Response Rate	Subjects may remain on study until disease progression.
Time-to-Progression (TTP)	Subjects may remain on study until disease progression.

Countries

Czechia, Greece, Hungary, Netherlands, Slovakia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026