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

• Conditions: Advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following one chemotherapy regimen in the advanced setting.; MedDRA version: 8.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2006-002830-38-HU
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Age ³ 18 years old.
2.The subject has pathologically (histologically and/or cytologically) documented NSCLC.
3.The subject has locally advanced (Stage III) NSCLC not amenable to curative surgery or radiotherapy or metastatic (Stage IV) NSCLC.
4.The subject has received only one prior anti-tumor treatment regimen in the advanced (Stage III non-curable disease or metastatic Stage IV) setting (i.e., study participation must be second line therapy in the advanced setting).
5.The subject may have received one additional anti-tumor treatment regimen in the neo-adjuvant or adjuvant setting.
6.The subject has experienced progressive disease either during or following the previous anti-tumor treatment regimen (Requirement for Phase 2 only).
7.The subject exhibits the presence of measurable disease by RECIST criteria (Requirement for Phase 2 only).
8.Subjects with brain metastases must have had clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 30 days of stable neurologic function and no evidence of CNS disease progression.
(Subjects with symptoms of CNS metastasis at Screening must have computed tomography [CT] or magnetic resonance imaging [MRI] scans of the brain prior to study entry that demonstrate no evidence of disease.)
9.The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
10.All anti-tumor therapy has been discontinued at least 3 weeks prior to study start administration.
11.All adverse events from prior anti-tumor treatment are resolved or stable.
12.Adequate hematologic, renal and hepatic function
13.Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a serum pregnancy test.
14.All female subjects not surgically sterile or postmenopausal (for at least 1 year) and non-vasectomized male subjects must practice at least one of the listed methods of birth control.
15.The subject's life expectancy is ³ 3 months.
16.The subject is amenable to completing the Quality of Life (QoL) questionnaire (Requirement for Phase 2 only).
17.Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any study specific procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.The subject has greater than Grade 1 NCI CTCAE (Version 3.07) neurology category findings (e.g., paresthesia, deep tendon reflexes, or weakness that is subjective and/or does not interfere with function).
2.The subject has a documented allergy to sulfa medications.
3.The subject has previously received ABT-751 or pemetrexed.
4.The subject has received more than one investigational agent for NSCLC as a single agent or part of a previous regimen. (An investigational agent is any drug not currently approved for use in humans. Please contact the Abbott medical monitor with questions regarding investigational agents.)
5.The subject exhibits significant weight loss (³ 10%) during the 6 weeks before study entry.
6.The subject has glucose-6-phosphate dehydrogenase deficiency and/or porphyria.
7.The subject has a significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease that would adversely affect his/her participating in this study. Questions regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor.
8.The subject has a current history of a Class 3-4 cardiovascular disability status in accordance with the New York Heart Association Functional Classification.
?Class 3 is defined as marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue or dyspnea.
?Class 4 is defined as being unable to carry on any physical activity without symptoms and symptoms are present even at rest. Also, if any physical activity is undertaken, symptoms are increased.
9.A female subject is pregnant or breastfeeding.
10.The subject has previous or current malignancies at other sites, with the exception of:
?adequately treated in situ carcinoma of the cervix uteri;
?basal or squamous cell carcinoma of the skin;
?previous nonpulmonary malignancy (e.g., localized prostate cancer) confined and surgically resected, treated with chemotherapy or radiation therapy, and is considered cured by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified