Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Vemurafenib

Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor

RO5185426

Clinical Trials

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.

A Study of RO5185426 in Patients With Metastatic Melanoma

A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA

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.

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.

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).

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. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. 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.

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.

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. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. 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.

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.

Hoffmann-La Roche

Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.

Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor

Overall Trial

Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.

Age, Continuous

Adolescents (12-17 year)

From 18 - 64 years

From 65 - 84 years

Over 85 years

Age, Customized

Sex: Female, Male

Safety population included all the participants who received at least one dose, or a partial dose of vemurafenib. Three participants who were enrolled did not receive vemurafenib hence not included in safety population.

Roche Trial Information Hotline

The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.

Number of Participants With Best Overall Response (Unconfirmed)

ECOG performance status 2 or 3; n=31

ECOG performance status 0 or 1; n=210

The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.

Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance

Number of Participants With Best Overall Response (Confirmed)

ECOG performance status 2 or 3); n= 31

ECOG performance status 0 or 1); n= 210

Number of Participants With Best Overall Response (Confirmed) by ECOG Performance

Mean time to confirmed CR or PR

Mean time to unconfirmed CR or PR

Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor

Mean Time to Complete Response/Partial Response

Any AE

Grade 3 AEs

Grade 4 AEs

Grade 5 AEs

AEs leading to discontinuation

The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.

Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation

Any SAEs

All Deaths

Death due to progression of disease

Death due to adverse event

Deaths which are not related to study drug

Deaths which are related to study drug

Number of Participants With Any Serious Adverse Event, Death and Cause of Death

Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.

Spots Global Cancer Trial Database for A Study of RO5185426 in Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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