A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

Neoplasms Clinical Trial

Official title:

An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773526
• Other study ID #: NO21895
• Secondary ID: 2008-002298-11
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: November 1, 2016
• Start date: November 2008
• Est. completion date: September 2011

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 dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• advanced and/or metastatic cancer not amenable to standard therapy;

• any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);

• measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);

• ECOG performance status 0-1.

Exclusion Criteria:

• prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;

• prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;

• known past or present CNS metastases;

• acute or chronic infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5126766
Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (Part 1)		Throughout study	No
Primary	Tumor assessments (Part 2)		Event driven	No
Secondary	AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).		Throughout study	No