A Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Malignant Melanoma
Intervention:	Drug: Vemurafenib 960 mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Vemurafenib 960 mg	Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.

Participant Flow: Overall Study

	Vemurafenib 960 mg
STARTED	132
COMPLETED	84
NOT COMPLETED	48
Death	40
Disease progression	7
Withdrawal of consent	1

Baseline Characteristics

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Reporting Groups

	Description
Vemurafenib 960 mg	Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.

Baseline Measures

	Vemurafenib 960 mg
Number of Participants [units: participants]	132
Age [units: years] Mean ± Standard Deviation	50.3 ± 14.70
Gender [units: participants]
Female	51
Male	81

Outcome Measures

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1. Primary:

Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: From first treatment through September 27, 2010 ]

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2. Secondary:

Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: From first treatment through September 27, 2010 ]

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3. Secondary:

Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: From first treatment through September 27, 2010 ]

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4. Secondary:

Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: From first treatment through September 27, 2010 ]

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5. Secondary:

Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: From first treatment through September 27, 2010 ]

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6. Secondary:

Overall Survival [ Time Frame: From first treatment through September 27, 2010 ]

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7. Secondary:

Improvement in Physical Symptoms (Improvement in Physician’s Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline [ Time Frame: From first treatment through September 27, 2010 ]

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8. Secondary:

Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1 [ Time Frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 ]

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9. Secondary:

Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1 [ Time Frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 ]

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10. Secondary:

Vemurafenib Plasma Levels at Various Treatment Cycles [ Time Frame: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1 ]

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11. Secondary:

Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP) [ Time Frame: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1 ]

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12. Secondary:

Percentage of Patients With Adverse Event [ Time Frame: From first treatment through September 27, 2010 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Sosman JA, Kim KB, Schuchter L, Gonzalez R, Pavlick AC, Weber JS, McArthur GA, Hutson TE, Moschos SJ, Flaherty KT, Hersey P, Kefford R, Lawrence D, Puzanov I, Lewis KD, Amaravadi RK, Chmielowski B, Lawrence HJ, Shyr Y, Ye F, Li J, Nolop KB, Lee RJ, Joe AK, Ribas A. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med. 2012 Feb 23;366(8):707-14.

Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00949702 History of Changes
Other Study ID Numbers:	NP22657
Study First Received:	July 28, 2009
Results First Received:	July 29, 2011
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration