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TerminatedNCT01581060Updated May 16, 2014

Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours

A Phase 1/2 interventional study of WX-554 in Advanced Solid Tumours, sponsored by Heidelberg Pharma AG. Terminated at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by Heidelberg Pharma AG · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study terminated for business reasons
Phase
Phase 1/2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of chronic treatment with WX-554.

02

Conditions studied

  • Advanced Solid Tumours

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    WX-554

    Drug: WX-554

Interventions

  • DrugWX-554

    Capsules of WX-554

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Cycle 1 (21 days)

  2. Part 1: Determination of the Maximum Tolerated Dose (MTD) for WX-554 by the evaluation of DLTs in 3-6 patients at the end of 1 treatment cycle

    Time frame: Cycle 1 (21 days)

  3. Part 2: To further determine the safety and tolerability by evaluating the incidence and severity of adverse events and serious adverse events (as per CTCAE grading), changes in hematology and chemistry values, vital signs, ECGs.

    Time frame: expected average of 3-6 months

Secondary outcomes

  1. Assessment of PK variables maximum observed concentration (Cmax), minimum observed concentration (Cmin), time at which Cmax was present (tmax), Area Under Curve (AUC)

    Time frame: PK profile on day 1 and day 8

  2. Assessment of ERK phosphorylation (pERK) in PBMC and tissue, assessment of TNF-alpha in plasma after oral intake of the OBD/MTD.

    Time frame: expected average of 3-6 months

  3. Tumour response evaluation using RECIST 1.1

    Time frame: expected average of 3-6 months

06

Study locations

5 sites
  • Queen's University Belfast Cancer Centre
    Belfast, BT9 7AB, United Kingdom
  • Beatson West of Scotland Cancer Centre
    Glasgow, G12 0YN, United Kingdom
  • St James' Institute of Oncology
    Leeds, LS9 7TF, United Kingdom
  • Christie NHS Foundation Trust, Oak Road Treatment Centre
    Manchester, M20 4BX, United Kingdom
  • Sir Bobby Robson Cancer Trials Research Centre
    Newcastle Upon Tyne, NE7 7DN, United Kingdom
07

Registry details

Key details

Study ID
NCT01581060
Lead sponsor
Heidelberg Pharma AG
Responsible party
Sponsor
First posted
Apr 19, 2012
Start date
Mar 2012
Primary completion
Apr 2014
Completion
Apr 2014
Last update
May 16, 2014

Study contacts

Ruth Plummer, MD
principal investigator · Sir Bobby Robson Cancer Trials Research Centre

Oversight

Data monitoring committee
No
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