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

AbbVie

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Cancer; Non-Small-Cell Lung Cancer; NSCLC

Treatments: Drug: placebo; Drug: pemetrexed; Drug: ABT-751

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297089

2006-002830-38 (EudraCT Number)

M05-780

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

165 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Pemetrexed + ABT-751

Treatment:

Drug: ABT-751

Drug: pemetrexed

B

Placebo Comparator group

Description:

Pemetrexed + placebo

Treatment:

Drug: pemetrexed

Drug: placebo