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A Phase I/II, Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor WX-554 in Patients With Solid Tumours


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumours

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Trial Information

A Phase I/II, Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor WX-554 in Patients With Solid Tumours


Inclusion Criteria:



1. Patients with advanced, metastatic and/or progressive solid tumours for whom there is
no effective standard therapy available.

2. Evaluable or measurable disease

3. Has normal organ functions; is no greater than 2 on the ECOG Performance Scale

4. life expectancy of >3 months

5. negative hCG test in women of childbearing potential

Exclusion Criteria:

1. Patients who received an investigational anti-cancer drug within 4 weeks of starting
the study

2. Patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of
starting the study

3. Clinically significant, unresolved toxicity from previous anti-cancer therapy
Patients

4. Patients who previously received a MEK inhibitor

5. Presence of active gastrointestinal disease or other condition that will interfere
significantly with the absorption, distribution, metabolism, or excretion of drugs.

6. Known medical history of retinal vein occlusion, intraocular pressure greater than 21
mm Hg or patient considered at risk of retinal vein thrombosis.

7. Known HIV positivity or active hepatitis B or C infection.

8. History of clinically significant cardiac condition

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Part 1: Determination of the Optimal Biological Dose (OBD) by the assessment of ERK phosphorylation (pERK) in peripheral blood mononuclear cells (PBMC) and assessment of TNF-alpha in plasma.

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:

Yes

Principal Investigator

Ruth Plummer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir Bobby Robson Cancer Trials Research Centre

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

WX/80-003

NCT ID:

NCT01581060

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Advanced Solid Tumours
  • Neoplasms

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