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

NCT00773526 | Completed Phase 1

• 2 other identifiers: NO218952008-002298-11
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (Part 1)

  Throughout study

• Tumor assessments (Part 2)

  Event driven

Secondary Outcomes (1)

• AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Drug: RO5126766

Interventions

RO5126766 DRUG

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).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

RO5126766

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1); FR (1); ES (1)