Glioblastoma Multiforme

Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.

Pazopanib

Centre Antoine Lacassagne

Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT

To evaluate the Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol, regarding the toxicities that should not be more than 33 %

To define the overall tolerance of pazopanib associated with TMZ during the maintenance phase of the "Stupp protocol" regarding biological toxicities, blood pressure and hemorragic events

To assess the antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol according to the Revised Assessment in Neuro-Oncology (RANO) criteria (response rate) and the median duration of response.

To determine the median Progression-Free-Survival (mPFS), the PFS rate at 12 (PFS-12) months.

To determine the median Overall Survival (mOS), the OS rate at 6 (OS-6) and 12 (OS-12) months.

To determine the pharmacokinetics (PK) profile of pazopanib when given in combination with TMZ.

To determine the pharmacokinetics (PK) profile of TMZ when given in combination with pazopanib.

GlaxoSmithKline

Standard arm foresees 3 cycles of preoperative chemotherapy, each cycle will be repeated every 21 days and includes: epirubicin 60 mg/m2/day, short infusion, days 1 and 2; ifosfamide 3 g/m2/day, days 1, 2, 3

gemcitabine+docetaxel for undifferentiated pleomorphic sarcoma, trabectedin for myxoid liposarcoma with hypercellularity, ifosfamide for synovial sarcoma, ifosfamide+etoposide for malignant peripheral nerve sheath tumor, gemcitabine+dacarbazine for leiomyosarcoma

Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults

epirubicin 60 mg/m2/day (days 1, 2) and ifosfamide 3 g/m2/day (days 1, 2, 3)

gemcitabine 900 mg/m2 (days 1 and 8) and docetaxel 75 mg/m2 (day 8)

trabectedin 1.3 mg/m2

high-dose ifosfamide 14 g/m2, given in in 14 days

etoposide 150 mg/m2/day (days 1, 2, 3) and ifosfamide 3g/m2/day (days 1, 2, 3)

gemcitabine 1800 mg/m2 (day 1) and dacarbazine 500 mg/m2 (day 1)

Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -

Irccs Centro Di Riferimento Oncologico (Cro) -

Irccs Istituto Ortopedico Rizzoli (Ior) -

Pres.Ospedal.Spedali Civili Brescia -

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori -

Irccs Istituto Europeo Di Oncologia (Ieo) -

Irccs Istituto Nazionale Dei Tumori (Int)

Irccs Istituto Nazionale Tumori Fondazione Pascale -

Irccs Istituto Oncologico Veneto (Iov)

Irccs Istituto Regina Elena (Ifo)

Irccs Istituto Clinico Humanitas -

Presidio Sanitario Gradenigo Di Torino

Hospital Vall D'Hebron

Hospital Clínico de Malaga

Hospital Son Espases

Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

Italian Sarcoma Group

French Sarcoma Group

Grupo Espanol de Investigacion en Sarcomas

Phase I: Cycles 1-4 (1 cycle = 28 days) Lenalidomide: 25 mg per day p.o., day 1 to 21 Dexamethasone: 40/20 mg per day p.o., days 1, 8, 15, 22 Nelfinavir: Dose escalation in cohorts of 3 patients
Phase II: Cycles 1-4 (1 cycle = 28 days) Lenalidomide: 25 mg per day p.o., day 1 to 21 Dexamethasone: 40/20 mg per day p.o., days 1, 8, 15, 22 Nelfinavir: Dose established in phase I twice daily p.o., day 1 to 21

Multiple Myeloma

In phase II, the recommended dose of nelfinavir will be administered orally twice daily (in the morning and in the evening) on d1-d21 every 28 days for a maximum of 4 cycles

Nelfinavir

25 mg of lenalidomide (capsules) will be administered orally daily on d1-d21 every 28 days for a maximum of 4 cycles

Lenalidomide

40 mg (for patients <75 years) or 20 mg (for patients ≥75 years) of dexamethasone (tablets) will be administered orally once per day on d1, 8, 15 and 22 every 28 days for a maximum of 4 cycles

Dexamethasone

SAKK - SWISS GROUP FOR CLINICAL CANCER RESEARCH

Istituto Europeo di Oncologia IEO

University of Torino

Kantonsspital Aarau

Kantonsspital Baden

Istituto Oncologico Svizzera Italiana IOSI

Inselspital Bern

Kantonsspital Graubünden

Kantonsspital Olten

Kantonsspital St. Gallen

Regionalspital

UniversitätsSpital Zürich

Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma

Nelfinavir and Lenalidomide/Dexamethasone in Patients With Progressive Multiple Myeloma That Have Failed Lenalidomide-containing Therapy - A Single Arm Phase I/II Trial

Swiss Group for Clinical Cancer Research

Colorectal Neoplasm

In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered i.v. via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min.

Cetuximab

Asan Medical Center

An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment

Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer

Frequency and severity of all AEs and serious adverse events; Laboratory information (haematology, clinical chemistry, EGFR test and KRAS test).

The following data will be collected:
Best tumor response with Erbitux treatment
Time to progression of tumor with Erbitux treatment
Duration of response with Erbitux treatment

asthenia/sarcoma

Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma

An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment

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