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Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
XL184
Placebo
Sponsored by
Exelixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Medullary Thyroid Cancer, MTC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject has a histologically confirmed diagnosis of MTC that cannot be removed by surgery, is locally advanced, or has spread in the body.
  • The subject is at least 18 years old.
  • The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
  • The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening.
  • The subject has recovered from clinically significant adverse events (side effects) due to any other medications that were administered prior to randomization.
  • The subject has adequate organ and bone marrow function.
  • Subjects who are sexually active (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments.
  • The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of malignancy (unless non-melanoma skin cancer or an early form of cervical cancer).
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

  • The subject has received prior treatment for their cancer within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C).
  • The subject has received radiation to ≥ 25 % of bone marrow.
  • The subject has received treatment with other investigational agents (unapproved therapies) within 4 weeks of randomization.
  • The subject has received treatment with XL184.
  • The subject has brain metastases or spinal cord compression, unless completed radiation therapy ≥ 4 weeks prior to randomization and stable without steroid and without anti-convulsant treatment for ≥ 10 days.
  • The subject has a history of clinically significant episodes of vomiting blood or a recent history of vomiting > 2.5 mL (about 1/2 teaspoon) of red blood.
  • The subject has serious illness other than cancer.
  • The subject is pregnant or breastfeeding.
  • The subject has an active infection requiring ongoing treatment.
  • The subject is incapable of understanding and complying with the protocol or unable to provide informed consent.

Sites / Locations

  • University of Alabama at Birmingham, Comprehensive Cancer Center
  • TGEN Clinical Research Service at Scottsdale Healthcare
  • University of Arkansas for Medical Sciences
  • UCLA
  • Stanford Cancer Center
  • University of Colorado Cancer Center
  • Yale University, School of Medicine
  • Washington Cancer Institute
  • H. Lee Moffet Cancer Center and Research Institute
  • University of Chicago
  • Indiana University Melvin and Bren Simon Cancer Center
  • University of Iowa
  • Kansas University Medical Center
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Henry Ford Health System
  • Mayo Clinic
  • Capitol Comprehensive Cancer Care Clinic and Research Institute
  • Washington University School of Medicine
  • Nebraska Methodist Hospital
  • Ohio State University, James Cancer Hospital
  • Oregon Health & Science University
  • St. Luke's Hospital & Health Network
  • Hospital of the University of Pennsylvania
  • Hollings Cancer Center
  • Vanderbilt University Medical Center
  • Vermont Cancer Center at Fletcher Allen Health Care
  • Peninsula Cancer Institute
  • Multiple site locations
  • Cliniques Universitaires St. Luc
  • Universitair Ziekenhuis
  • Multiple site locations
  • CHUM - Hopital Saint-Luc
  • Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen
  • Gemeinschaftspraxis
  • Universitaetsklinikum Leipzig
  • Johannes-Gutenberg Universitaet Mainz
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
  • Ludwig-Maximilians-Universitaet Muenchen
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum Wuerzburg
  • Kidwai Institute of Oncology
  • Indo-American Cancer Institute and Research Center
  • SEAROC Cancer Institute, S.K. Soni Hospital
  • Netaji Subhash Chandra Bose Cancer Hospital Research Institute
  • Central India Cancer Research Institute
  • Shatabdi Superspeciality Hospital
  • All India Institute of Medical Sciences
  • Deenanath Mangeshkar Hospital & Research Center
  • Ruby Hall Clinic
  • Multiple site locations
  • Multiple site locations
  • Multiple site locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.

Secondary Outcome Measures

Overall Survival (OS) With XL184 Compared With Placebo
Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.
Objective Response Rate (ORR)
The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR
Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.
Biochemical Response Calcitonin (CTN) %
For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.
Biochemical Response Carcinoembryonic Antigen (CEA) %
For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.

Full Information

First Posted
June 23, 2008
Last Updated
March 30, 2021
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT00704730
Brief Title
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
Acronym
EXAM
Official Title
An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Medullary Thyroid Cancer, MTC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
XL184
Intervention Description
Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Gelatin capsules color and size-matched to XL184 capsules administered orally daily
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.
Time Frame
Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.
Secondary Outcome Measure Information:
Title
Overall Survival (OS) With XL184 Compared With Placebo
Description
Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.
Time Frame
The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.
Title
Objective Response Rate (ORR)
Description
The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR
Time Frame
Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.
Title
Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
Description
For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.
Time Frame
From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.
Title
Biochemical Response Calcitonin (CTN) %
Description
For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.
Time Frame
Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.
Title
Biochemical Response Carcinoembryonic Antigen (CEA) %
Description
For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.
Time Frame
Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has a histologically confirmed diagnosis of MTC that cannot be removed by surgery, is locally advanced, or has spread in the body. The subject is at least 18 years old. The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2. The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening. The subject has recovered from clinically significant adverse events (side effects) due to any other medications that were administered prior to randomization. The subject has adequate organ and bone marrow function. Subjects who are sexually active (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments. The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of malignancy (unless non-melanoma skin cancer or an early form of cervical cancer). Female subjects of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: The subject has received prior treatment for their cancer within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C). The subject has received radiation to ≥ 25 % of bone marrow. The subject has received treatment with other investigational agents (unapproved therapies) within 4 weeks of randomization. The subject has received treatment with XL184. The subject has brain metastases or spinal cord compression, unless completed radiation therapy ≥ 4 weeks prior to randomization and stable without steroid and without anti-convulsant treatment for ≥ 10 days. The subject has a history of clinically significant episodes of vomiting blood or a recent history of vomiting > 2.5 mL (about 1/2 teaspoon) of red blood. The subject has serious illness other than cancer. The subject is pregnant or breastfeeding. The subject has an active infection requiring ongoing treatment. The subject is incapable of understanding and complying with the protocol or unable to provide informed consent.
Facility Information:
Facility Name
University of Alabama at Birmingham, Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
TGEN Clinical Research Service at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University, School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
H. Lee Moffet Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic and Research Institute
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Ohio State University, James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital & Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vermont Cancer Center at Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
City
Klagenfurt
Country
Austria
Facility Name
Multiple site locations
City
Wien
Country
Austria
Facility Name
Cliniques Universitaires St. Luc
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis
City
Leuven
Country
Belgium
City
Brasilia
Country
Brazil
City
Lajeado
Country
Brazil
City
Porto Alegre
Country
Brazil
Facility Name
Multiple site locations
City
Sao Paulo
Country
Brazil
City
Calgary
State/Province
Alberta
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHUM - Hopital Saint-Luc
City
Montreal
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
City
Santiago
Country
Chile
City
Odense
Country
Denmark
City
Angers
Country
France
City
Bordeaux
Country
France
City
Lyon
Country
France
City
Marseille
Country
France
City
Reims
Country
France
City
Villejuif
Country
France
Facility Name
Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen
City
Essen
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Heidelberg
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Johannes-Gutenberg Universitaet Mainz
City
Mainz
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
City
Muenchen
Country
Germany
Facility Name
Ludwig-Maximilians-Universitaet Muenchen
City
Muenchen
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
Country
Germany
City
Athens
Country
Greece
Facility Name
Kidwai Institute of Oncology
City
Bangalore
Country
India
Facility Name
Indo-American Cancer Institute and Research Center
City
Hyderabad
Country
India
Facility Name
SEAROC Cancer Institute, S.K. Soni Hospital
City
Jaipur
Country
India
Facility Name
Netaji Subhash Chandra Bose Cancer Hospital Research Institute
City
Kolkata
Country
India
Facility Name
Central India Cancer Research Institute
City
Nagpur
Country
India
Facility Name
Shatabdi Superspeciality Hospital
City
Nashik
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Dehli
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Center
City
Pune
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
City
Haifa
Country
Israel
City
Jerusalem
Country
Israel
City
Petach Tikva
Country
Israel
City
Tel Aviv
Country
Israel
City
Florence
Country
Italy
City
Milan
Country
Italy
City
Naples
Country
Italy
City
Pisa
Country
Italy
City
Rome
Country
Italy
City
Siena
Country
Italy
City
Turin
Country
Italy
Facility Name
Multiple site locations
City
Seoul
Country
Korea, Republic of
City
Amsterdam
Country
Netherlands
City
Groningen
Country
Netherlands
City
Leiden
Country
Netherlands
Facility Name
Multiple site locations
City
Lima
Country
Peru
City
Bydgoszcz
Country
Poland
City
Gliwice
Country
Poland
City
Pozan
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Coimbra
Country
Portugal
City
Oporto
Country
Portugal
City
Porto
Country
Portugal
City
Obninsk
Country
Russian Federation
City
Ufa
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Riyadh
Country
Saudi Arabia
Facility Name
Multiple site locations
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Murcia
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Sevilla
Country
Spain
City
Valencia
Country
Spain
City
Gothenburg
Country
Sweden
City
Lund
Country
Sweden
City
Uppsala
Country
Sweden
City
Berne
Country
Switzerland
City
Geneve
Country
Switzerland
City
Cardiff
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29045520
Citation
Schlumberger M, Elisei R, Muller S, Schoffski P, Brose M, Shah M, Licitra L, Krajewska J, Kreissl MC, Niederle B, Cohen EEW, Wirth L, Ali H, Clary DO, Yaron Y, Mangeshkar M, Ball D, Nelkin B, Sherman S. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017 Nov 1;28(11):2813-2819. doi: 10.1093/annonc/mdx479.
Results Reference
derived
PubMed Identifier
24002501
Citation
Elisei R, Schlumberger MJ, Muller SP, Schoffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3. Erratum In: J Clin Oncol. 2014 Jun 10;32(17):1864.
Results Reference
derived

Learn more about this trial

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

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