---
title: A Study of RO5045337 in Patients With Solid Tumors
nct_id: NCT01164033
overall_status: COMPLETED
phase: PHASE1
sponsor: Hoffmann-La Roche
study_type: INTERVENTIONAL
primary_condition: Neoplasms
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01164033.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01164033"
ct_last_update_post_date: 2016-11-02
last_seen_at: "2026-05-12T06:42:31.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of RO5045337 in Patients With Solid Tumors

**Official Title:** 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

**NCT ID:** [NCT01164033](https://clinicaltrials.gov/study/NCT01164033)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 76
- **Lead Sponsor:** Hoffmann-La Roche
- **Conditions:** Neoplasms
- **Start Date:** 2010-08
- **Completion Date:** 2013-05
- **CT.gov Last Update:** 2016-11-02

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **A** (ACTIVE_COMPARATOR)
- **B** (EXPERIMENTAL)
- **C** (EXPERIMENTAL)
- **D** (EXPERIMENTAL)

## Interventions

- **RO5045337** (DRUG) — single oral dose

## Primary Outcomes

- **Examination of potential food-effect on pharmacokinetics of RO5045337** _(time frame: 3 weeks)_
- **Evaluation of relative bioavailability of RO5045337** _(time frame: 3 weeks)_

## Secondary Outcomes

- **Evaluation of safety and tolerability of RO5045337** _(time frame: 3 weeks)_
- **Evaluation of pharmacodynamics and biomarkers** _(time frame: 3 weeks)_

## Locations (5)

- Scottsdale, Arizona, United States
- Kansas City, Kansas, United States
- Kensignton, Maryland, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States

## Recent Field Changes (last 30 days)

- `locations.|san antonio|texas|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.|kansas city|kansas|united states` — added _(2026-05-12)_
- `locations.|kensignton|maryland|united states` — added _(2026-05-12)_
- `locations.|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01164033.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01164033*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*