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 or more chemotherapy regimens.; MedDRA version: 8.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age = 18 years old.
2. The subject has histologically-documented NSCLC.
3. The subject has locally advanced (Stage III) or metastatic (Stage IV) NSCLC not
amenable to curative surgery or radiotherapy.
4. The subject has received at least 1 prior treatment regimen for NSCLC in the
neo-adjuvant, adjuvant or metastatic setting.
5. The subject has received no more than 2 prior treatment regimens for NSCLC
(i.e., study participation must be second-line therapy in the metastatic setting).
6. The subject has received no more than 1 chemotherapy treatment regimen in the
metastatic setting.
7. The subject has experienced progressive disease either during or following the
previous chemotherapy regimen.
8. The subject exhibits the presence of measurable disease by RECIST criteria.
9. 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.)
10. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
score of 0-2.
11. All anti-tumor therapy has been discontinued at least 3 weeks prior to study start
administration.
12. All adverse events from prior anti-tumor treatment are resolved or stable.
13. Adequate hematologic, renal and hepatic function: no NYHA Class 3-4 heart failure
14. Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a serum pregnancy test.
15. 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 following
methods of birth control:
? Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start);
? Vasectomized partner;
? Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to and during study drug administration;
Double-barrier method (condoms, contraceptive sponge, diaphragm, or
vaginal ring with spermicidal jellies or creams).
16. The subject's life expectancy is = 3 months.
17. The subject is amenable to completing the Quality of Life (QoL) questionnaire.
18. 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 3.0) 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 (= 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 with no evidence of disease within three years of
initiation of study
? previous nonpulmonary malignancy, which has been treated with surgery,
chemotherapy, or radiation therapy and is considered cured by the
investigator, may be approved by the Abbott Medical Monitor.

Study & Design

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