Advanced Solid TumoursPhase 1/2NCT01581060
Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours
A Phase 1/2 study testing WX-554 in people with Advanced Solid Tumours, run by Heidelberg Pharma AG at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- WX-554
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.
- Evaluable or measurable disease
- Has normal organ functions; is no greater than 2 on the ECOG Performance Scale
- life expectancy of >3 months
- negative hCG test in women of childbearing potential
Who cannot join
- Patients who received an investigational anti-cancer drug within 4 weeks of starting the study
- Patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
- Clinically significant, unresolved toxicity from previous anti-cancer therapy Patients
- Patients who previously received a MEK inhibitor
- 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.
- Known HIV positivity or active hepatitis B or C infection.
- History of clinically significant cardiac condition
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Queen's University Belfast Cancer Centre
Belfast, BT9 7AB
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
St James' Institute of Oncology
Leeds, LS9 7TF
Christie NHS Foundation Trust, Oak Road Treatment Centre
Manchester, M20 4BX
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, NE7 7DN
About this study
Official title: 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
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.
- Conditions
- Advanced Solid Tumours
- Being tested
- WX-554
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX-554Drug
Capsules of WX-554
| Study group | Role | What they receive |
|---|---|---|
| WX-554 | Experimental | Not described Receives: Drug: WX-554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cycle 1 (21 days)
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
Measured: Cycle 1 (21 days)
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.
Measured: expected average of 3-6 months
Secondary outcomes (3)
Assessment of PK variables maximum observed concentration (Cmax), minimum observed concentration (Cmin), time at which Cmax was present (tmax), Area Under Curve (AUC)
Measured: PK profile on day 1 and day 8
Assessment of ERK phosphorylation (pERK) in PBMC and tissue, assessment of TNF-alpha in plasma after oral intake of the OBD/MTD.
Measured: expected average of 3-6 months
Tumour response evaluation using RECIST 1.1
Measured: expected average of 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study terminated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth Plummer, MD, Principal investigator, Sir Bobby Robson Cancer Trials Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581060
- Sponsor's protocol ID
- WX/80-003
- Other IDs
- 2011-003408-19
- Status last verified
- May 2014
- First submitted
- 28 Mar 2012
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01581060
- Acronym / sponsor ID
- WX/80-003
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for business reasons
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WX-554 | Experimental | Drug: WX-554 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.
- Evaluable or measurable disease
- Has normal organ functions; is no greater than 2 on the ECOG Performance Scale
- life expectancy of >3 months
- negative hCG test in women of childbearing potential
Key exclusion criteria (8 listed)
- Patients who received an investigational anti-cancer drug within 4 weeks of starting the study
- Patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
- Clinically significant, unresolved toxicity from previous anti-cancer therapy Patients
- Patients who previously received a MEK inhibitor
- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WX-554Capsules of WX-554 | Drug | WX-554 |
Primary outcome
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)
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)
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
3 secondary outcomes
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
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
Tumour response evaluation using RECIST 1.1
Time frame: expected average of 3-6 months
Results and safety
The study was stopped early (reason given: Study terminated for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Related trials for Advanced Solid Tumours
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Plummer, MD principal investigator
Sir Bobby Robson Cancer Trials Research Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WX-554 in people with Advanced Solid Tumours, run by Heidelberg Pharma AG at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated for business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Cycle 1 (21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.