A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER

• Register: EUCTR
• Last refreshed on: 7 September 2021
• Main ID: EUCTR2004-001467-22-ES
• Date of registration: 29/09/2004
• Prospective Registration: Yes
• Primary sponsor: Pfizer S.A.
• Public title: A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER
• Scientific title: A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 26/10/2004
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001467-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV):

Countries of recruitment

Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically proven NSCLC (Stage IV or recurrent disease or locally advanced [Stage IIIB]) that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
2. Must have received no more than 2 prior systemic chemotherapy regimens including treatment with platinum and docetaxel (Taxotere)-containing regimens.
3. Must have evidence of progression of disease within 6 months of most recent prior systemic anticancer therapy.
4. Completion of all prior chemotherapy, immunotherapy, and radiotherapy > /equal to 4 weeks prior to study entry, and resolution of all acute toxic effects of any prior systemic anticancer therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade minor/equal to 1.
5. Evidence of unidimensionally measurable disease (i.e., > /equal 1 malignant tumor mass that may be accurately measured in at least 1 dimension > /equal to 20 mm with conventional radiographic techniques or magnetic resonance imaging [MRI], or if spiral computerized tomography [CT] scan, twice the reconstruction interval used [lesion size > /equal to 10-16 mm depending on interval]). Tumor evaluation by positron emission tomography (PET) scan or by ultrasound may not substitute for CT or MRI scans. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions, and disease documented by indirect evidence only (e.g., by laboratory tests such as alkaline phosphatase) are not considered measurable.
6. Male or female, 18 years of age or older.
7. ECOG performance status 0 or 1.
8. Adequate organ function as defined by the following criteria:
· Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) [SGPT] minor/equal to 2.5 x upper limit of normal (ULN)
· Total serum bilirubin minor/equal to1.5 mg/dL
· Prothrombin time (PT) minor/equal to1.5 x ULN
· Absolute neutrophil count (ANC) major/equal to 1500/mL
· Platelets major/equal to 100,000/mL
· Hemoglobin major/equal to 9.0 g/dL
· Serum creatinine minor/equal to 1.5 x ULN
· Left ventricular ejection fraction (LVEF) major/equal to 50% as assessed by multigated acquisition (MUGA) scan
9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study 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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
2. NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment.
3. Evidence of hemoptysis <4 weeks of starting study treatment
4. Uncontrolled hypertension.
5. Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of PDGFR. Previous treatment with IressaÒ is permitted.
6. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
7. History of, or known, brain metastases, spinal cord compression or carcinomatous meningitis or evidence of brain or leptomeningeal disease on screening CT or MRI scan.
8. Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, pulmonary embolism or cerebrovascular accident.
9. Ongoing cardiac dysrhythmias of NCI CTCAE grade major/equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
10. Known human immunodeficiency virus (HIV) infection.
11. Current treatment on another clinical trial.
12. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 21 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
14. Receipt of any investigational agent within 4 weeks prior to study entry. Previous treatment with SU011248


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Histologically proven NSCLC (Stage IV or recurrent disease or locally advanced [Stage IIIB]) that is not amenable to surgery, radiation, or combined modality therapy with curative intent

Intervention(s)

Product Name: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sal L-malato de SU011248
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12,5 -
INN or Proposed INN: Sal L-malato de SU011248
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Sal L-malato de SU011248
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): Overall confirmed objective response rate (ORR).

Secondary Objective: To assess duration of response·
To assess time to progression·
To assess survival·
To evaluate the safety and tolerability of SU011248 ·
To evaluate SU011248 and SU012662 trough concentrations (Cmin) and to correlate these plasma concentrations with efficacy and safety parameters·
To explore the relationship of cancer biomarkers with cancer and treatment-related outcomes

Main Objective: To determine the antitumor efficacy of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients having metastatic NSCLC who have previously failed a platinum-containing regimen and docetaxel (Taxotere)

Secondary ID(s)

A6181040

Ethics review

Status: Approved
Approval date: 30/09/2004
Contact:

Results

• Results available: Yes
• Date Posted: 24/07/2016
• Date Completed: 19/03/2007
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-001467-22/results