NCT00949702

Brief Summary

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 22, 2011

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2014

Completed
Last Updated

July 25, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

July 28, 2009

Results QC Date

July 29, 2011

Last Update Submit

June 26, 2017

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

    BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.

    From first treatment through September 27, 2010

Secondary Outcomes (11)

  • Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

    From first treatment through September 27, 2010

  • Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

    From first treatment through September 27, 2010

  • Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

    From first treatment through September 27, 2010

  • Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

    From first treatment through September 27, 2010

  • Overall Survival

    From first treatment through September 27, 2010

  • +6 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL
Drug: vemurafenib

Interventions

vemurafenibDRUG

960 mg b.i.d. continuous oral dosing

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients \>/=18 years of age
  • histologically confirmed metastatic melanoma (Stage IV, AJCC)
  • patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
  • BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
  • measurable disease by RECIST criteria
  • negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

You may not qualify if:

  • active CNS metastases on CT/MRI within 28 days prior to enrollment
  • history of or known carcinomatous meningitis
  • previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
  • cardiac dysrhythmias \>2 NCI CTCAE or treatment with drugs with dysrhythmic potential
  • uncontrolled hypertension(\>150/100mmHg) despite optimal medical therapy
  • infectious disease including HIV, HBV and HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

UCLA - School of Medicine; Division of Hematology/Oncology

Los Angeles, California, 90095-6984, United States

Location

University of Colorado

Denver, Colorado, 80262, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital;Hematology/ Oncology

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Inst. ; Dept. of Medical Oncology

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York University Medical Center

New York, New York, 10036, United States

Location

Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Calvary Mater Newcastle; Melanoma Clinic

Newcastle, New South Wales, 2298, Australia

Location

Westmead Hospital; Medical Oncology and Pallative Care

Westmead, New South Wales, 2145, Australia

Location

Peter Maccallum Cancer Institute; Medical Oncology

Melbourne, Victoria, 3000, Australia

Location

Related Publications (5)

  • Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

    PMID: 32746839DERIVED

  • Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.

    PMID: 24983357DERIVED

  • Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.

    PMID: 23457002DERIVED

  • 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. doi: 10.1056/NEJMoa1112302.

    PMID: 22356324DERIVED

  • 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. doi: 10.1056/NEJMoa1105358.

    PMID: 22256804DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Vemurafenib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 30, 2009

Study Start

September 30, 2009

Primary Completion

September 27, 2010

Study Completion

June 3, 2014

Last Updated

July 25, 2017

Results First Posted

December 22, 2011

Record last verified: 2017-06

Locations

AU(3)US(12)