NCT01286753

Brief Summary

This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Typical duration for phase_2

Geographic Reach
4 countries

16 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

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

July 1, 2016

Enrollment Period

3.4 years

First QC Date

January 28, 2011

Results QC Date

July 22, 2016

Last Update Submit

July 22, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Best Overall Response Rate in TKI-Naive Participants

    Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \< 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.

    Up to approximately 4 years

Secondary Outcomes (7)

  • Best Overall Response Rate in TKI-Experienced Participants

    Up to approximately 4 years

  • Clinical Benefit Rate

    Up to approximately 4 years

  • Duration of Response

    From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)

  • Progression-Free Survival

    From the day of first treatment until the first documented PD or death (up to approximately 4 years)

  • Overall Survival

    From the date of first treatment to the date of death for any cause (up to approximately 4 years)

  • +2 more secondary outcomes

Study Arms (2)

Tyrosine Kinase Inhibitor (TKI) Naive

EXPERIMENTAL

Vemurafenib in participants naive to any prior systemic TKI therapy.

Drug: Vemurafenib

TKI Experienced

EXPERIMENTAL

Vemurafenib in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).

Drug: Vemurafenib

Interventions

VemurafenibDRUG

Vemurafenib 960 mg orally twice daily.

Also known as: Zelboraf®, RO5185426
TKI ExperiencedTyrosine Kinase Inhibitor (TKI) Naive

Eligibility Criteria

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

You may qualify if:

  • Adult participants. \>/= 18 years of age
  • Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of "other histology" may be enrolled, provided the tumor histology remains predominantly papillary
  • Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)
  • Radioactive Iodine resistant disease
  • Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI
  • Clinically relevant disease progression according to RECIST criteria within the prior 14 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematological, renal and liver function

You may not qualify if:

  • Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia
  • Active or untreated central nervous system metastases
  • History of or known carcinomatous meningitis
  • Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study
  • Active squamous cell skin cancer that has not been excised or adequately healed post excision
  • Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway
  • Prior radiotherapy to the only measurable lesion
  • Clinically relevant cardio-vascular disease or event within the prior 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Torrance, California, 90502, United States

Location

Unknown Facility

New Haven, Connecticut, 06510, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Baltimore, Maryland, 21231, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

New York, New York, 10017, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Lyon, 69008, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Milan, Lombardy, 20133, Italy

Location

Unknown Facility

Pisa, Tuscany, 56124, Italy

Location

Unknown Facility

Groningen, 9700 RB, Netherlands

Location

Unknown Facility

Leiden, 2300 RC, Netherlands

Location

Related Publications (1)

  • Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23.

    PMID: 27460442DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Vemurafenib

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

September 7, 2016

Results First Posted

September 7, 2016

Record last verified: 2016-07

Locations

IT(2)US(9)FR(3)NL(2)