A Phase 1 interventional study of RO5045337 in Sarcoma, sponsored by Hoffmann-La Roche. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.
143 studies on the registry are indexed under Liposarcoma; 37 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 119 interventional studies indexed under Liposarcoma.
Browse Liposarcoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RO5045337
orally day 1-10 each 28-day cycle, 3 cycles
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Time frame: from baseline to week 12
Safety and tolerability: Adverse events, laboratory parameters, ECG
Time frame: up to approximately 4 months after study start
Tumor response according to RECIST criteria assessed by CT or MRI
Time frame: from baseline to week 7
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
Time frame: multiple sampling weeks 1 and 2
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche