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A Study of RO5045337 in Patients With Solid Tumors

NCT ID: NCT01164033

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

RO5045337

Intervention Type DRUG

single oral dose

B

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

single oral dose

C

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

single oral dose

D

Group Type EXPERIMENTAL

RO5045337

Intervention Type DRUG

single oral dose

Interventions

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RO5045337

single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Scottsdale, Arizona, United States

Site Status

Kansas City, Kansas, United States

Site Status

Kensignton, Maryland, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Patnaik 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.

Reference Type DERIVED
PMID: 26210682 (View on PubMed)

Other Identifiers

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NP25299

Identifier Type: -

Identifier Source: org_study_id