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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01248936
Other study ID # ML25597
Secondary ID
Status Completed
Phase Phase 2
First received November 24, 2010
Last updated January 13, 2016
Start date December 2010
Est. completion date October 2011

Study information

Verified date January 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test

- Patients with clinical evidence of disease progression during or after at least one prior systemic therapy for metastatic melanoma

- Patients with either measurable or non-measurable disease

- Adequate recovery from most recent systemic or local treatment for metastatic melanoma

- Adequate organ function

- For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426

- For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426

- Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study

- Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

- Evidence of symptomatic CNS lesions as determined by investigator

- Patients with a previous malignancy within the past 2 years are excluded except for patients with basal or squamous cell carcinoma (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

- Pregnant or breast-feeding

- Concurrent anti-tumor therapy

- Any of the following within 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

- Uncontrolled medical illness

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RO5185426


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade. Up to 1 year No
Primary Number of Participants With Any Serious Adverse Event, Death and Cause of Death Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded. Up to 1 year No
Secondary Number of Participants With Best Overall Response (Unconfirmed) The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1). Up to 1 year No
Secondary Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The 'n' is number of participants with ECOG performance status in each criteria. Up to 1 year No
Secondary Number of Participants With Best Overall Response (Confirmed) The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1. Up to 1 year No
Secondary Number of Participants With Best Overall Response (Confirmed) by ECOG Performance The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Participants were assessed for best overall response by investigator as per RECIST v1.1. The 'n' is number of participants with ECOG performance status in each criteria. Up to 1 year No
Secondary Mean Time to Complete Response/Partial Response Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1. Up to 1 year No
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