Clinical trial · Interventional
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer, Ovarian Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO5323441 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: RO5323441
Primary outcomes (1)
- measure
- RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
- timeFrame
- up to 19.5 months
Secondary outcomes (6)
- measure
- Feasibility of within-patient dose escalation
- timeFrame
- from baseline to Day 127 (+/-3)
- measure
- Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
- timeFrame
- up to 19.5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>/=19 years of age * metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy * presence of tumor lesions suitable for DCE-MRI evaluation * WHO performance status 0-1 * adequate bone marrow, liver and renal function Exclusion Criteria: * patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material) * brain metastases * clinically significant ascites * active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders * radiation therapy within 3 weeks, or anti-neoplastic therapy \<30 days prior to first dose of study drug * chronic therapy with systemic steroids or another immunosuppressive agent \<2 weeks prior to first dose of study drug * treated with bevacizumab in last regimen of systemic therapy
References
Publications (0)
Data not yet available