Clinical trial · Interventional
A Study of RO5045337 in Patients With Solid Tumors
An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
NCT01164033CI-TRIAL-00024639completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.
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 (4)
- type
- ACTIVE_COMPARATOR
- label
- A
- interventionNames
- Drug: RO5045337
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: RO5045337
- type
- EXPERIMENTAL
- label
- C
- interventionNames
- Drug: RO5045337
- type
- EXPERIMENTAL
- label
- D
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Histologically confirmed solid tumor * Life expectancy of \>/=12 weeks * ECOG performance status of 0 or 1 * Adequate bone marrow, renal and hepatic function Exclusion Criteria: * Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start * Patients with pre-existing gastro-intestinal disorder * Patients with uncontrolled intercurrent illness
References
Publications (1)
- DERIVEDPatnaik A, Tolcher A, Beeram M, Nemunaitis J, Weiss GJ, Bhalla K, Agrawal M, Nichols G, Middleton S, Beryozkina A, Sarapa N, Peck R, Zhi J. Clinical pharmacology characterization of RG7112, an MDM2 antagonist, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):587-95. doi: 10.1007/s00280-015-2830-8. Epub 2015 Jul 26. PMID 26210682