A Study of RO5045337 in Patients With Solid Tumors | NCT01164033

Studies
A Study of RO5045337 in Patients With Solid Tumors

NCT01164033

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

76Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

RO5045337

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 15, 2010

First Submission Date that Met QC Criteria

Jul 15, 2010

First Posted Date

Jul 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A	Active Comparator	Drug: RO5045337
B	Experimental	Drug: RO5045337
C	Experimental	Drug: RO5045337
D	Experimental	Drug: RO5045337

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RO5045337	Drug	single oral dose	A B C D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Examination of potential food-effect on pharmacokinetics of RO5045337		3 weeks
Evaluation of relative bioavailability of RO5045337		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of safety and tolerability of RO5045337		3 weeks
Evaluation of pharmacodynamics and biomarkers		3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Scottsdale	Arizona	85258	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26210682	Derived	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.