Back to resultsSafety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy (AIM-HN/SEQ-HN)
Primary Purpose
HRAS Gene Mutation, HNSCC
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tipifarnib
HRAS Detection Assay
Sponsored by
About this trial
This is an interventional treatment trial for HRAS Gene Mutation focused on measuring TIPIFARNIB, HEAD AND NECK CANCER
Eligibility Criteria
Inclusion Criteria:
AIM-HN
- At least 18 years of age.
- Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Documented treatment failure from most recent prior therapy (e.g. tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting.
- Known tumor missense HRAS mutation.
- Measurable disease by RECIST v1.1.
- ECOG performance status of 0-1.
- Acceptable liver, renal and hematological function
- Other protocol defined inclusion criteria may apply.
Exclusion Criteria:
- Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
- Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
- Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy. Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
- Received treatment for non-cancer related liver disease within prior year.
- Other protocol defined exclusion criteria may apply
Inclusion Criteria: SEQ-HN
- At least 18 years of age.
- Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
- Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
- HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
- Other protocol defined inclusion criteria may apply
Exclusion Criteria: SEQ-HN
1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
5. Other protocol defined exclusion criteria may apply
Sites / Locations
- University of Southern California Norris Comprehensive Cancer Center
- UCLA - Jonsson Comprehensive Cancer Center
- UCSF - Helen Diller Family Comprehensive Cancer Center
- The Oncology Institute of Hope and Innovation - Anaheim
- Miami Cancer Institute
- University of South Florida H. Lee Moffitt Cancer Center and Research Institute
- Winship Cancer Institute
- University of Chicago
- University Of Kansas Medical Center
- University of Kentucky Markey Cancer Center
- Norton Cancer Institute
- Greater Baltimore Medical Center
- Marlene and Stewart Greenebaum Cancer Center
- Dana Farber Cancer Institute
- Barbara Ann Karmanos Cancer Institute
- Mayo Clinic
- Siteman Cancer Center - Washington University Medical Campus
- New York University Langone Medical Center
- Memorial Sloan Kettering Cancer Center
- Levine Cancer Institute
- The Ohio State University
- University of Oklahoma Health Sciences Center
- Fox Chase Cancer Center
- Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center
- San Antonio Military Medical Center
- The University of Texas MD Anderson Cancer Center
- University of Texas Health San Antonio - Mays Cancer Center
- Seattle Cancer Care Alliance
- University of Wisconsin
- Peter MacCallum Cancer Centre
- Royal North Shore Hospital
- Allgemeines Krankenhaus der Stadt Wien
- Hanusch Krankenhaus Wiener Gebietskrankenkasse
- Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
- Ziekenhuis Netwerk Antwerpen Middelheim
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Antwerpen
- Universitair Ziekenhuis Leuven
- Rigshospitalet
- Herlev Hospital
- Charité Universitätsmedizin Berlin
- Universitätsklinikum Leipzig
- Universitätsmedizin Mannheim
- Universitätsklinikum Würzburg
- University General Hospital of Athens Attikon
- University General Hospital of Larissa
- Bioclinic - Thessaloniki
- Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
- Azienda Ospedaliera S. Croce e Carle Cuneo
- Ospedale Mater Salutis di Legnago
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
- Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
- Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
- National Cancer Center
- Chonbuk National University Hospital
- Korea University Anam Hospital
- Yonsei University Health System Severance Hospital
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea - Seoul St. Mary's Hospital
- The Catholic University of Korea St. Vincent's Hospital
- University Malaya Medical Centre
- Institut Kanser Negara
- Universitair Medisch Centrum Groningen
- Maastricht University Medical Centre
- Universitair Medisch Centrum Utrecht
- Haukeland Universitetssjukehus
- Radiumhospitalet
- Hospital del Mar - Parc de Salut Mar
- Hospital de la Santa Creu i de Sant Pau
- Hospital Universitari Vall d'Hebrón
- Hospital Clinic i Provincial de Barcelona
- Hospital Duran i Reynals
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- HM Centro Integral Oncológico Clara Campal
- Hospital Costa Del Sol
- Hospital Universitario Virgen de la Victoria
- Complejo Hospitalario de Navarra
- Hospital Clínico Universitario de Santiago de Compostela
- Hospital Universitario Virgen del Rocio
- Hospital Universitari i Politecnic La Fe de Valencia
- Hospital Universitario Miguel Servet
- Changhua Christian Hospital
- Kaohsiung Chang Gung Memorial Hospital
- Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Mackay Memorial Hospital
- National Taiwan University Hospital
- Chang Gung Memorial Hospital
- King Chulalongkorn Memorial Hospital
- Maharaj Nakorn Chiang Mai Hospital
- Songklanagarind Hospital
- Guy's and Saint Thomas' NHS Foundation Trust
- NHS Greater Glasgow and Clyde
- University College London Hospitals NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
- The Christie NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AIM-HN
SEQ-HN
Arm Description
Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Outcomes
Primary Outcome Measures
Objective Response Rate in High Variable Allele Frequency (VAF) population
complete response and partial response
Secondary Outcome Measures
Objective Response Rate in any VAF population
Determine anti-tumor activity of tipifarnib
Duration of Response in High VAF population
Determine anti-tumor activity of tipifarnib
Duration of Response in any VAF population
Determine anti-tumor activity of tipifarnib
Progression Free Survival in both high VAF and all VAF populations
Determine anti-tumor activity of tipifarnib
Overall survival in both high VAF and all VAF populations
Determine anti-tumor activity of tipifarnib
Overall survival in both high VAF and all VAF populations
Determine anti-tumor activity of tipifarnib
Investigate safety and tolerability of tipifarnib according to NCI CTCAE v5.0
Incidence of adverse events, incidence of abnormal laboratory test results, abnormal vital signs, and abnormal ECG results
Time to Response in both high VAF and all VAF populations
Determine anti-tumor activity of tipifarnib
Time to Progression in both high VAF and all VAF populations
Determine anti-tumor activity of tipifarnib
Investigate effects of tipifarnib treatment on quality of life using EORTC QLQ-H&N35
Measured by changes of quality of life using the EORTC QLQ-H&N35
Evaluate the concentration of tipifarnib [pharmacokinetics (PK)] in blood samples over time
Measured by blood samples collected during the first 6 cycles of treatment
Investigate effects of tipifarnib treatment on quality of life using EQ-5D-5L
Measured by changes of quality of life using the EQ-5D-5L.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03719690
Brief Title
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
Acronym
AIM-HN/SEQ-HN
Official Title
A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kura Oncology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Detailed Description
KO-TIP-007 is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN) and the impact of HRAS mutations on response to first line systemic therapies for HNSCC (SEQ-HN). KO-TIP-007 has 2 study cohorts. The first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. AIM-HN subjects will receive treatment with tipifarnib and the outcome of this cohort will be evaluated for ORR by an independent review facility.
The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. These patients will be followed and the comparison of outcomes of HRAS mutant and HRAS wild type HNSCC will address the exploratory objective to determine the effect of HRAS mutation on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. Outcome data from subsequent lines of therapy will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HRAS Gene Mutation, HNSCC
Keywords
TIPIFARNIB, HEAD AND NECK CANCER
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
284 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AIM-HN
Arm Type
Experimental
Arm Description
Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
Arm Title
SEQ-HN
Arm Type
No Intervention
Arm Description
HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Intervention Type
Drug
Intervention Name(s)
Tipifarnib
Intervention Description
Tablet for oral administration
Intervention Type
Device
Intervention Name(s)
HRAS Detection Assay
Intervention Description
In Vitro Assay to detect HRAS mutations
Primary Outcome Measure Information:
Title
Objective Response Rate in High Variable Allele Frequency (VAF) population
Description
complete response and partial response
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate in any VAF population
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Duration of Response in High VAF population
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Duration of Response in any VAF population
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Progression Free Survival in both high VAF and all VAF populations
Description
Determine anti-tumor activity of tipifarnib
Time Frame
6 and 9 months
Title
Overall survival in both high VAF and all VAF populations
Description
Determine anti-tumor activity of tipifarnib
Time Frame
1 year
Title
Overall survival in both high VAF and all VAF populations
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Investigate safety and tolerability of tipifarnib according to NCI CTCAE v5.0
Description
Incidence of adverse events, incidence of abnormal laboratory test results, abnormal vital signs, and abnormal ECG results
Time Frame
30 days after treatment discontinuation
Title
Time to Response in both high VAF and all VAF populations
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Time to Progression in both high VAF and all VAF populations
Description
Determine anti-tumor activity of tipifarnib
Time Frame
2 years
Title
Investigate effects of tipifarnib treatment on quality of life using EORTC QLQ-H&N35
Description
Measured by changes of quality of life using the EORTC QLQ-H&N35
Time Frame
2 years
Title
Evaluate the concentration of tipifarnib [pharmacokinetics (PK)] in blood samples over time
Description
Measured by blood samples collected during the first 6 cycles of treatment
Time Frame
6 months
Title
Investigate effects of tipifarnib treatment on quality of life using EQ-5D-5L
Description
Measured by changes of quality of life using the EQ-5D-5L.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AIM-HN
At least 18 years of age.
Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
Documented treatment failure from most recent prior therapy (e.g. tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting.
Known tumor missense HRAS mutation.
Measurable disease by RECIST v1.1.
ECOG performance status of 0-1.
Acceptable liver, renal and hematological function
Other protocol defined inclusion criteria may apply.
Exclusion Criteria:
Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy. Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
Received treatment for non-cancer related liver disease within prior year.
Other protocol defined exclusion criteria may apply
Inclusion Criteria: SEQ-HN
At least 18 years of age.
Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
Other protocol defined inclusion criteria may apply
Exclusion Criteria: SEQ-HN
1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
5. Other protocol defined exclusion criteria may apply
Facility Information:
Facility Name
University of Southern California Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA - Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF - Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation - Anaheim
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University Of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center - Washington University Medical Campus
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health San Antonio - Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Royal North Shore Hospital
City
Saint Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch Krankenhaus Wiener Gebietskrankenkasse
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
University General Hospital of Athens Attikon
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Bioclinic - Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale Mater Salutis di Legnago
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea - Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Institut Kanser Negara
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Haukeland Universitetssjukehus
City
Bergen
ZIP/Postal Code
1521
Country
Norway
Facility Name
Radiumhospitalet
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Hospital del Mar - Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
HM Centro Integral Oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Costa Del Sol
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago De Compostela
ZIP/Postal Code
15707
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
20442
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10099
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Guy's and Saint Thomas' NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
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