A Phase 1 interventional study of RO5323441 in Colorectal Cancer, Ovarian Cancer, sponsored by Hoffmann-La Roche. Completed at 3 sites in 3 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is \<100.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms 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: RO5323441
cohorts receiving multiple doses iv
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
Time frame: up to 19.5 months
Feasibility of within-patient dose escalation
Time frame: from baseline to Day 127 (+/-3)
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
Time frame: up to 19.5 months
Candidate biomarkers associated with PD effect of RO5323441
Time frame: up to 19.5 months
Pharmacokinetics: maximum and trough concentrations of RO5323441
Time frame: up to 19.5 months
Safety and tolerability: Adverse events, vital signs, laboratory parameters
Time frame: up to 19.5 months
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments
Time frame: up to 19.5 months
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