Regorafenib 160mg once a day, frequency: 3 weeks on/1 week off in cycles of 28 days

Gastrointestinal Stromal Tumors

Treatment with regorafenib 160mg once a day, 3 weeks on / 1 week off in cycles of 28 days

regorafenib

Institute Bergonie

Centre Leon Berard

Gustave Roussy

Fondazione IRCCS Istituto Dei Tumori di Milano

Istituto Clinico Humanitas Milano

Policlinico Universitario Campus Bio-Medico

Istituto di Candiolo - IRCSS

Hospital Universitario de Canarias

Hospital de Cruces

Hospital Universitario Vall d´hebron

Hospital de la Santa Creu i Sant Pau

Hospital Universitario Gregorio Marañon

Hospital Universitario La Paz

Hospital Universitario Virgen del Rocío

Hospital Universitario Virgen de la Macarena

Instituto Valenciano de Oncología

Hospital Universitario Miguel Servet

Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST

Phase II, Single Arm, Non-randomized and Multicenter Clinical Trial of Regorafenib as a Single Agent in the First-line Setting for Patients With Metastatic and/or Unresectable KIT/PDGFR Wild Type GIST

the sum of complete responses (CR) + partial responses (PR) + stable disease (SD).

Relation between the clinical data obtained and the data obtained from translational research

Evaluation of adverse events following CTCAE v4.03

Evaluation of metabolic response to treatment

Grupo Espanol de Investigacion en Sarcomas

Bayer

Patients receive pazopanib hydrochloride PO QD on days 1-28 (days 1-14 of courses 1 and 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.

Treatment: Pazopanib Without Run-in

Cycle 1:
Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 2:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.
Cycle 3 and beyond:
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.

Treatment: Pazopanib With Run-in

Total

Sex: Female, Male

Region of Enrollment

Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test.
Complete Response (CR): All of the following must be true:
Disappearance of all target and non-target lesions.
Each lymph node must have reduction in short axis to <1.0 cm.
Partial Response (PR):
At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference.
Overall Response (OR) was calculated by summing the number of patients with a CR or PR.

Treatment: Pazopanib With no Run-in

Treatment: Pazopanib Run-in

Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1

Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.

Duration of Tumor Response

Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method.

Overall Survival Time

Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method.

Progression-free Survival Time

The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years.

Time to Treatment Failure

Overall Study

Keith Bible, M.D., Ph.D.

Extra-Adrenal Paraganglioma

Metastatic Adrenal Gland Pheochromocytoma

Paraganglioma

Recurrent Adrenal Gland Pheochromocytoma

Laboratory Biomarker Analysis

Pazopanib Hydrochloride

Mayo Clinic in Arizona

Mayo Clinic in Florida

Johns Hopkins University/Sidney Kimmel Cancer Center

University of Michigan Comprehensive Cancer Center

Mayo Clinic

Metro-Minnesota NCI Community Oncology Research Program

Washington University School of Medicine

M D Anderson Cancer Center

University of Wisconsin Hospital and Clinics

Chinese University of Hong Kong-Prince of Wales Hospital

National University Hospital Singapore

Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma

A Phase 2 Study of Pazopanib (GW786034) in Patients With Advanced and Progressive Malignant Pheochromocytoma or Paraganglioma

National Cancer Institute (NCI)

Altitude Intolerance

High-Altitude Illness

Centre d'Investigation Clinique, Hopital Pompidou

Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness

Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness Associated With Chemoreflex Failure

Société Française de Cardiologie