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A Phase I Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the PI3K Inhibitor WX-037, Given as a Single Agent and in Combination With the MEK Inhibitor WX-554, in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumours

Thank you

Trial Information

A Phase I Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the PI3K Inhibitor WX-037, Given as a Single Agent and in Combination With the MEK Inhibitor WX-554, in Patients With Solid Tumors


Inclusion Criteria:



- Patients with advanced, metastatic and/or progressive solid tumors for whom there is
no effective standard therapy available (for part 2 in addition patients for whom
their PI3K pathway is deregulated)

- Evaluable or measurable disease

- Has normal organ function; is no greater than 2 on the ECOG performance scale

- Negative hCG test in women of childbearing potential

Exclusion Criteria:

- History of diabetes requiring daily medication or history of grade 3 or more fasting
hyperglycemia

- Patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of
starting the study

- Clinical significant, unresolved toxicity from previous anti-cancer therapy

- Patients who previously received a MEK inhibitor (for combination part only)

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

- Known medical history of retinal vein occlusion, intraocular pressure greater than 21
mm Hg or patient considered at risk of retinal vein thrombosis (combination part
only)

- Known HIV positivity or active hepatitis B or C infection

- History of clinically significant cardiac condition

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of Dose limiting toxicities

Outcome Time Frame:

during cycle 1 (21days) of treatment with WX-037

Safety Issue:

Yes

Principal Investigator

Udai Banerji, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

WX/90-001

NCT ID:

NCT01859351

Start Date:

May 2013

Completion Date:

June 2015

Related Keywords:

  • Advanced Solid Tumours
  • Neoplasms

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