Advanced Solid TumoursPhase 1NCT01859351
Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours
A Phase 1 study testing WX-037 and WX-554 in people with Advanced Solid Tumours, run by Heidelberg Pharma AG at 3 sites in United Kingdom.
Trial 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). 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-037 and WX-554
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 1
- 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 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Guy's and St Thomas' Foundation Trust, Guy's Hospital
London, SE1 9RT
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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
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.
- Conditions
- Advanced Solid Tumours
- Being tested
- WX-037, WX-554
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX-037Drug
WX-554Drug
| Study group | Role | What they receive |
|---|---|---|
| WX-037 | Experimental | PI3K inhibitor Receives: Drug: WX-037 |
| WX-037 in combination with WX-554 | Experimental | PI3K inhibitor in combination with MEK inhibitor Receives: Drug: WX-037; Drug: WX-554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose limiting toxicities
Measured: during cycle 1 (21days) of treatment with WX-037
Incidence of Dose Limiting toxicities
Measured: during cycle 1 (21 days) of treatment with WX-037 and WX-554
Secondary outcomes (3)
Number of patients with adverse Events and serious adverse events
Measured: from cycle 1 day 1 until treatment discontinuation, an estimated average of 18 weeks
Assessment of PK variables, peak plasma concentration (Cmax), area under the curve (AUC)
Measured: two PK profiles in cycle 1
Determination of PD markers; changes from baseline in biomarkers of pathway inhibition
Measured: predose until treatment discontinuation, an estimated average of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJul 2013
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Udai Banerji, MD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859351
- Sponsor's protocol ID
- WX/90-001
- Other IDs
- 2012-004552-11
- Status last verified
- May 2014
- First submitted
- 23 Apr 2013
- 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 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
- ClinicalTrials.gov ID
- NCT01859351
- Acronym / sponsor ID
- WX/90-001
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for business reasons
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 May 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WX-037 | Experimental | Drug: WX-037PI3K inhibitor |
| WX-037 in combination with WX-554 | Experimental | Drug: WX-037, Drug: WX-554PI3K inhibitor in combination with MEK inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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-037 | Drug | WX-037, WX-037 in combination with WX-554 |
| WX-554 | Drug | WX-037 in combination with WX-554 |
Primary outcome
Incidence of Dose limiting toxicities
Time frame: during cycle 1 (21days) of treatment with WX-037
Incidence of Dose Limiting toxicities
Time frame: during cycle 1 (21 days) of treatment with WX-037 and WX-554
3 secondary outcomes
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
Assessment of PK variables, peak plasma concentration (Cmax), area under the curve (AUC)
Time frame: two PK profiles in cycle 1
Determination of PD markers; changes from baseline in biomarkers of pathway inhibition
Time frame: predose until treatment discontinuation, an estimated average of 18 weeks
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
Neoplasms
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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.
Udai Banerji, MD principal investigator
Royal Marsden NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WX-037 and WX-554 in people with Advanced Solid Tumours, run by Heidelberg Pharma AG at 3 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 4 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 3 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 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.
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?
Incidence of Dose limiting toxicities (time frame: during cycle 1 (21days) of treatment with WX-037). The study lists 2 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.