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An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a 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 or other responsive tumor type
(Part 2);

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

- ECOG performance status 0-2.

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;

- active CNS lesions;

- acute or chronic infection.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (Part 1)

Outcome Time Frame:

Reviewed after each 4 week cycle

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Netherlands: Medicines Evaluation Board

Study ID:

BO21189

NCT ID:

NCT00817518

Start Date:

January 2009

Completion Date:

May 2013

Related Keywords:

  • Neoplasms
  • Neoplasms

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