A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Docetaxel Versus Docetaxel 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
- EUCTR2006-002838-38-IE
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. The subject is = 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 following the previous
chemotherapy regimen.
8. The subject has 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 = 2.
11. All prior anti-tumor therapy must be discontinued at least 3 weeks prior to
ABT-751/placebo and docetaxel administration.
12. All adverse events from prior anti-tumor treatment are resolved or stable.
13. The subject's life expectancy is = 3 months.
14. The subject must have adequate hematologic, renal and hepatic function as
follows:
Hematology
Absolute Neutrophil Count (ANC) = 2000/mm3
Platelet Count = 100,000/mm3
Hemoglobin = 9.0 g/dL
Renal Function
Creatinine Serum = 2.0 mg/dL or
Creatinine Clearance = 45 mL/mina
Hepatic Function
Bilirubin = 1.5 mg/dL (= 3.0 mg/dL with liver metastasis)b
Serum Glutamic-Oxaloacetic
Tranaminase (SGOT)
= 2.5 × ULN (= 5.0 × ULN with liver metastasis)
Serum Glutamic-Pyruvic
Tranaminase (SGPT)
= 2.5 × ULN (= 5.0 × ULN with liver metastasis)
a. If calculated creatinine clearance is < 45 mL/min, a 24-hour urine collection for creatinine clearance
may be performed.
b. Subjects with Gilbert's disease may have bilirubin up to 2.5 mg/dL (or 3.0 mg/dL with liver
metastasis).
15. Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or
have negative results for a serum pregnancy test.
16. 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;
ABT-751
M05-782 Protocol Amendment 2
EudraCT 2006-002838-38
? Hormonal contraceptives (oral, parenteral, or transdermal) for at least
3 months prior to and during study drug administration;
? Double-barrier method (condoms, contraceptive sponge, or vaginal ring with
spermicidal jellies or creams).
17. The subject is amenable to completing the Quality of Life (QoL) questionnaire.
18. The subject has voluntarily signed and dated an informed consent form, approved
by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB),
prior to any non-routine study-specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 yea
1. The subject has NCI CTCAE (version 3.0) neurology category findings
(e.g., paresthesia, impaired deep tendon reflexes, or weakness) greater than
Grade 1.
2. The subject has a documented allergy to sulfa medications.
3. The subject has glucose-6-phosphate dehydrogenase deficiency.
4. The subject has porphyria.
5. The subject has previously received ABT-751 or docetaxel.
6. 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.)
7. The subject exhibits significant weight loss (= 10%) during the 6 weeks before
study entry.
8. 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.
9. 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.
10. A female subject who is pregnant or breastfeeding.
11. 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) surgically
resected or curatively treated with no evidence of disease within three years of
study initiation.
? 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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the Phase 1 portion of the study, which will be conducted in the US and Canada only, is to determine the maximum tolerated dose (MTD) of ABT-751 when administered daily for 14/21 days, in combination with standard docetaxel (75 mg/m2 every 21 days).The primary objective of the Phase 2 portion of the study (estimated to begin enrollment in Sep-Nov 2006) is to assess the impact on progression-free survival of the combination of ABT-751 docetaxel compared to docetaxel alone in subjects with NSCLC who have received at least one prior chemotherapy regimen.;Secondary Objective: The secondary objectives of the Phase 2 portion of the study will be overall survival, response rate, duration of response, time-to-progression (TTP), quality of life (QoL), and to characterize toxicities associated with ABT-751 when administered in combination with docetaxel.;Primary end point(s): Primary - Progression-free survival
- Secondary Outcome Measures
Name Time Method