None listed
Conditions
Interventions
Group 1 Type of group
XL184 will be administered once a day (qd) in a single dose of 175 mg, in capsules of 25 to 100 mg. Each treatment cycle will last 4 weeks.
Group name:Group 2 Type of group
The placebo will be administered once a day (qd) in capsules of 25 to 100 mg. Each treatment cycle will last 4 weeks.
Sponsors
EXELISIS, INC.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • • The patient has a histologically confirmed diagnosis of MTC that is inoperable, locally advanced or metastatic and disease that is measurable or not measurable according to mRECIST. • The patient must be at least 18 years old. • The patient has an ECOG performance status (Eastern Group of Cooperative Oncology) • The patient has progressive disease (PD) documented in computed tomography (CT), magnetic resonance imaging (MRI) bone mapping, or X-rays (confirmed by the independent central blind review committee [IRC]) according to mRECIST, in the time of the selection and compared to the image made in the period of 14 months prior to the selection. • The patient has recovered consistently with grade 1500 / mm ^ 3, platelets> 100 000 / mm ^ 3, hemoglobin> 9 g / dl, bilirubin <1.5 times the limit higher than normal (does not apply to patients with Gilbert´s syndrome), creatinine <1.5 mg / dl and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ^, 5 times greater than the normal upper limit. • Sexually active patients should not be able to use medically accepted methods of contraception during the study and for 3 months after the end of the study treatments (except for women who have no potential to leave pregnant and men who went through sterilization processes) . • The patient has no other malignant diseases (with the exception of skin cancer without melanoma, carcinoma in situ in the cervix, and malignant disease diagnosed two years earlier) and currently does not present evidence of malignancy (with the exception of skin cancer without melanoma or carcinoma in situ in the cervix). • Women with the potential to leave pregnant should present a negative pregnancy test at the time of selection. Women with the potential to get pregnant are those sexually mature who did not go through a hysterectomy or who had any evidence of menstruation during the last 12 months. However, women who presented amenorrhea for 12 months or more, still have the potential to get pregnant if the amenorrhea is due to previous chemotherapy, antiestrogen or ovarian suppression treatment.
Exclusion criteria
Exclusion criteria: • The patient previously received systemic antitumor therapy (for example, chemotherapy, biological modifiers or antiangiogenic therapy), at least 4 weeks before random selection (6 weeks for nitrosoureas or mitomycin C). • The patient who received radiation on> 25% of the bone marrow. • The patient who received treatment with other experimental agents within 4 weeks prior to randomization. • The patient who received treatment with XLl 84. • The patient presenting with metastases in the brain or spinal cord compression, unless radiation therapy has ended> 4 weeks before randomization and the patient has presented a stable condition without> steroid treatment for> 10 days anticonvulsants • The patient has a history of clinically significant hematemesis or recent history of hemoptysis> 2.5 ml of red blood or other signs of pulmonary hemorrhage or evidence of endobronchial lesion (s). • The patient has a protein / creatinine ratio in the urine> 1 (reported in grams of protein over grams of creatinine). • The patient presenting with severe interciurent disease, such as hypertension (two or more readings made in the selection of systolic blood pressure> 140 mmHg or diastolic blood pressure> 90mmHg) despite adequate treatment, uncured wounds from recent surgeries or rhythm disorders heart disease, or a recent history of serious illness such as congestive heart failure or unstable pectoral angina within the last 3 months, or myocardial infarction, stroke or transient ischemic accident within the last 6 months. • The patient is pregnant or breastfeeding. • The patient has an active infection that requires systemic treatment. • The patient has an allergy or hypersensitivity to any of the components of XLl 84 or the placebo formulas (Sections 6.2 and 6.3). • The patient is unable to understand and follow the protocol or does not have conditions to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed. Measure:Progression-Free Survival (PFS) Timepoints:Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median. Measure:Overall Survival (OS) With XL184 Compared With Placebo Timepoints:The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached ; Outcome name:The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR Measure:Objective Response Rate (ORR) Timepoints:Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months. ; Outcome name:For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause. Measure:Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined Timepoints:From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months. ; Outcome name:For each on-treatment tumor marker assessment from each subject, t | — |
Countries
Arabia Saudi, Austria, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, India, Israel, Italy, Korea South, Netherlands, Peru, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed