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Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859351
Recruitment Status : Terminated (Study terminated for business reasons)
First Posted : May 21, 2013
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Wilex

Brief Summary:
The purpose of this study is to test the safety of escalating doses of the novel PI3K inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumours Drug: WX-037 Drug: WX-554 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: WX-037
PI3K inhibitor
Drug: WX-037
Experimental: WX-037 in combination with WX-554
PI3K inhibitor in combination with MEK inhibitor
Drug: WX-037
Drug: WX-554



Primary Outcome Measures :
  1. Incidence of Dose limiting toxicities [ Time Frame: during cycle 1 (21days) of treatment with WX-037 ]
  2. Incidence of Dose Limiting toxicities [ Time Frame: during cycle 1 (21 days) of treatment with WX-037 and WX-554 ]

Secondary Outcome Measures :
  1. Number of patients with adverse Events and serious adverse events [ Time Frame: from cycle 1 day 1 until treatment discontinuation, an estimated average of 18 weeks ]
  2. Assessment of PK variables, peak plasma concentration (Cmax), area under the curve (AUC) [ Time Frame: two PK profiles in cycle 1 ]
  3. Determination of PD markers; changes from baseline in biomarkers of pathway inhibition [ Time Frame: predose until treatment discontinuation, an estimated average of 18 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859351


Locations
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United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Guy's and St Thomas' Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Wilex
Investigators
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Principal Investigator: Udai Banerji, MD Royal Marsden NHS Foundation Trust
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Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT01859351    
Other Study ID Numbers: WX/90-001
2012-004552-11 ( EudraCT Number )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Neoplasms