Molecular Profiling of Advanced Soft-tissue Sarcomas

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

603

Participants

Timeline

Start Date

October 19, 2019

Primary Completion Date

December 1, 2023

Study Completion Date

October 31, 2025

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Nilotinib

Target: KIT, PDGFRA, CSF1R Nilotinib will be administered orally, 400 mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

Ceritinib

Target: ALK, ROS. Ceritinib will be administered orally, 450mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

Capmatinib

Target: MET. Capmatinib will be administered orally, 400mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

Lapatinib

Target: ERBB2, EGFR. Lapatinib will be administered orally, 1500mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

Trametinib

Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K. Trametinib will be administered orally, 2 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

COMBINATION_PRODUCT

Trametinib and Dabrafenib

"Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K, BRAF. Trametinib will be administered orally, 2mg once daily on a continuous basis. Dabrafenib will be administered orally, 150mg twice daily, on a continuous basis.~A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation."

COMBINATION_PRODUCT

Olaparib and Durvalumab

Target: PDL1, PARP. Olaparib will be administered orally, 300mg twice daily on a continuous basis. Dabrafenib will be administered intraveinously, 1500mg on day 1 every 4 weeks. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

Palbociclib

"Target: CDK4, CDK6. Palbociclib will be administered orally, 125mg once daily, 3 weeks on/1 week off.~A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation."

DRUG

Glasdegib

Target: SMO. Glasdegib will be administered orally, 300 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

DRUG

TAS-120

Target: FGFR. TAS-120 will be administered orally, 20 mg once daily on a continuous basis. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.

OTHER

Next Generation sequencing exome

Both frozentumor material (archived or newly obtained) and blood sample collection will be used for genetic profiling

Trial Locations (19)

35042

Centre Eugène Marquis, Rennes

67033

ICANS - Institut de Cancérologie Strasbourg, Strasbourg

86000

CHU Poitiers, Poitiers

Unknown

Institut Bergonie, Bordeaux

Centre Jean Perrin, Clermont-Ferrand

Centre Georges François Leclerc, Dijon

Centre Oscar Lambret, Lille

Centre Léon Bérard, Lyon

Hôpital La Timone, Marseille

Institut Paoli Calmettes, Marseille

Institut de Cancérologie de Montpellier, Montpellier

Centre Antoine Lacassagne, Nice

Hôpital Cochin, Paris

Hôpital Pitié Salpétrière, Paris

Institut Curie, Paris

Centre Henri Becquerel, Rouen

Institut de Cancérologie de l'Ouest - Site René Gauducheau, Saint-Herblain

IUCT Oncopôle, Toulouse

Institut Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

Commissariat A L'energie Atomique

OTHER_GOV

collaborator

Institut Bergonié

OTHER

collaborator

Plateforme labellisée Inca - Institut Bergonié, Bordeaux

UNKNOWN

collaborator

Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris

UNKNOWN

collaborator

EUCLID Clinical Trial Platform

OTHER

lead

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV