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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (Part 1)

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21895

NCT ID:

NCT00773526

Start Date:

November 2008

Completion Date:

August 2012

Related Keywords:

  • Neoplasms
  • Neoplasms

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