A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:

A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559533
• Other study ID #: NO21280
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2007
• Last updated: November 1, 2016
• Start date: December 2007
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5045337
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD and associated dose schedule		Every 28 days	No
Secondary	Clinical response		Event driven	No
Secondary	Dose-limiting toxicities.		Throughout study	No
Secondary	Pharmacokinetic profile		Throughout study	No
Secondary	Comparison safety and tolerability of daily versus twice daily dosing regimens		approximately 18 months	No