Clinical trial · Interventional
A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors
A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
- 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 study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO5045337 | Drug | RG7112 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: RO5045337
Primary outcomes (1)
- measure
- MTD and associated dose schedule
- timeFrame
- Every 28 days
Secondary outcomes (4)
- measure
- Clinical response
- timeFrame
- Event driven
- measure
- Dose-limiting toxicities.
- timeFrame
- Throughout study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * solid tumor malignancies; * failed prior therapies, or no standard therapy available; * ECOG performance status of 0-2. Exclusion Criteria: * patients receiving any other agent or therapy to treat their malignancy; * pre-existing gastrointestinal disorders which may interfere with absorption of drugs; * clinically significant cardiovascular disease.
References
Publications (0)
Data not yet available