An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
- Conditions
- aggressive skin cancermetastatic melanoma10040900
- Registration Number
- NL-OMON39617
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
In het engels:
A patient may be included if the answer to all of the following statements is yes.
1. Male or female patients * 18 years of age
2. Patients with histologically confirmed metastatic melanoma (Stage IV, AJCC)
with documented BRAF V600 mutation as determined be the cobas® BRAF
V600 Mutation Test prior to administration of RO5185426.
3. Patients with either measurable or non-measurable disease (RECIST Version 1.1).
4. Patients must have progressed during or after at least one prior systemic treatment
for metastatic melanoma
5. ECOG PS of 0-2
6. Patients must have recovered from all side effects of their most recent systemic or
local treatment for metastatic melanoma
7. Adequate hematologic, renal and liver function as defined by the following
laboratory values performed within 7 days prior to first dose of RO5185426:
* ANC * 1.5 x 109/L
* Platelet count * 100 x 109/L
* Hemoglobin * 9 g/dL
* Serum creatinine * 1.5 times ULN or CrCl > 50 mL/hr by Cockroft*Gault
formula
* AST and ALT * 2.5 times ULN (*5 times ULN if considered due to tumor)
* Serum Bilirubin * 1.5 times ULN
* Alkaline phosphatase * 2.5 times ULN (* 5 times ULN if considered due to
tumor)
8. Negative serum pregnancy test within 7 days prior to commencement of dosing in
premenopausal women. Women of non-childbearing potential may be included if they
are either surgically sterile or have been postmenopausal for * 1 year
9. Fertile men and women must use an effective method of contraception during
treatment and for at least 6 months after completion of treatment as directed by their
physician. Effective methods of contraception are defined as those which result in a
low failure rate (i.e. less than 1% per year) when used consistently and correctly (for
example implants, injectables, combined oral contraception or intra-uterine devices).
At the discretion of the investigator, acceptable methods of contraception may include
total abstinence in cases where the lifestyle of the patient ensures compliance.
CONFIDENTIAL Roche Protocol MO25515 (RO5185426) - Page 40
[Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods)
and withdrawal are not acceptable methods of contraception.]
10. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before trial entry
11. Signed informed consent must be obtained prior to performing any study-related
procedures (including tumor testing for the V600 BRAF mutation)
1. Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426. Patients with asymptomatic lesions previously irradiated or surgically resected that are radiologically stable are eligible. Patients with incidentally found brain metastasis that are asymptomatic and for which no treatment is planned are also eligible
2. Patients with a previous malignancy (other than melanoma) within the past 2 years
are excluded except for patients with treated and controlled basal or SCC of the skin
or carcinoma in-situ of the cervix. Isolated elevation in PSA in absence of
radiographic evidence of metastatic prostate cancer is allowed
3. Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other
targeted therapy, experimental drug, etc) other than those administered in this study
4. Pregnant or lactating women
5. Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant
bowel resection that would preclude adequate absorption. Patients must be able to
swallow tablets
6. Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, pulmonary embolism,
hypertension not adequately controlled by current medications
7. History of or presence of clinically significant ventricular or atrial dysrhythmias *
Grade 2 (NCI CTCAE Version 4.0)
8. Corrected QT (QTc) interval * 450 msec at baseline
9. Uncontrolled medical illness such as infection requiring treatment with IV antibiotics
10. 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, which in
the judgment of the investigator would make the patient inappropriate for entry into
this study
11. Unwillingness to practise effective birth control
12. Inability to comply with other requirements of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: To evaluate the safety and tolerability of RO5185426 in<br /><br>patients with metastatic melanoma (Stage IV; AJCC) harboring<br /><br>the BRAF V600 mutation</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: To evaluate the efficacy of RO5185426 as objective<br /><br>response rates (ORRs) determined by the investigator (RECIST,<br /><br>Version 1.1) as allowed by local regulatory requirements. </p><br>