CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Gamma-Secretase Inhibitor RO4929097 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01154452
NCT01154452Phase 2Completed
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A Phase 1B/II Study of GDC-0449 (NSC 747691) in Combination With RO4929097, a Gamma-Secretase Inhibitor (GSI) in Advanced/Metastatic Sarcomas

National Cancer Institute (NCI)·interventional·Posted Jun 30, 2010·Updated Aug 15, 2018

In Brief

A Phase 2 clinical trial evaluating Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, and 2 other interventions for Adult Alveolar Soft Part Sarcoma and 34 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This randomized phase I/II clinical trial is studying the side effects and best dose of gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with vismodegib and to see how well they work in treating patients with advanced or metastatic sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Alveolar Soft Part Sarcoma, Adult Angiosarcoma, Adult Desmoplastic Small Round Cell Tumor, Adult Epithelioid Hemangioendothelioma, Adult Epithelioid Sarcoma, Adult Extraskeletal Myxoid Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Mesenchymoma, Adult Malignant Peripheral Nerve Sheath Tumor, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Adult Unclassified Pleomorphic Sarcoma, Chondrosarcoma, Clear Cell Sarcoma of the Kidney, Conjunctival Kaposi Sarcoma, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Osteosarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Adult Unclassified Pleomorphic Sarcoma of Bone, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Kaposi Sarcoma, Recurrent Osteosarcoma, Recurrent Uterine Corpus Sarcoma, Small Intestine Leiomyosarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Unclassified Pleomorphic Sarcoma of Bone
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2010
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.0 years ago

Interventions

Gamma-Secretase Inhibitor RO4929097drug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Vismodegibdrug

Given PO