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

Phase 2

Completed

Conditions: Lungcancer
Non Small Cell Lung Carcinoma
10038666
10029107

Registration Number: NL-OMON30442

Lead Sponsor: Abbott

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1.Age minimum 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.

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.
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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: progression free surfival<br /><br><br /><br>Safety:<br /><br>Adverse Events, laboratory values, ECGs, physical examinations and vital signs<br /><br>will be examined during the study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>secundary: surfival, tumor respons ratio, respons time, time till progression,<br /><br>quality of life.</p><br>

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