Solid TumorsPhase 1NCT01222546
Study of CH5132799 Administered Orally in Patients With Advanced Solid Tumors
A Phase 1 study testing CH5132799 in people with Solid Tumors, run by Chugai Pharma Europe Ltd. at 1 site in United Kingdom.
Trial summary
This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CH5132799
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Dec 2012
- 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
- Provision of signed written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Life expectancy of ≥ 12 weeks.
- Disease measurability:
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- Patients must have a measurable - as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 - and/or evaluable disease.
- Paraffin-embedded archival tumor tissue available. Fresh biopsies will be required if no paraffin embedded tumor tissues available.
- Adequate bone marrow function.
- Adequate cardiac function: Patient should have Left Ventricular Ejection Fraction (LVEF) of ≥ 50% as determined by echocardiography (ECHO) or Multi Gated Acquisition (MUGA) scans.
- Adequate liver function.
- Adequate renal function.
- Adequate adrenal function assessed by baseline cortisol of > 200 nmol/L
- Ability to comply with protocol requirements.
- Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients who have been sterilized must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment.
- Female patients of child-bearing potential must have a negative serum pregnancy test within the seven days prior to the first study drug administration.
Who cannot join
- History of allergic reactions attributed to components of the formulated product.
- Inability to swallow oral medications or impaired gastrointestinal absorption due to active inflammatory bowel disease.
- Known Central Nervous System (CNS) metastases or leptomeningeal metastases will be eligible only if it could be radiologically demonstrated that there is no CNS disease progression during the 3 months prior to the study
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled hypertension
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug, with exception of prostate cancer if indicated.
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- Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade ≤ 1 severity - National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0).
- Type 1 or 2 diabetes mellitus requiring regular medication and/or a fasting plasma glucose (FPG) ≥ 120 mg/dL (or 6.6 mmol/dL) at screening.
- Increased QTc interval (QTc > 450 ms for male; > 460 ms for female).
- History of heart failure, refractory hypokalemia to adequate supplementation, family history of long QT syndrome or other risk factors for "Torsades de Pointes", and/or the use of concomitant medications that prolong the QT/QTc interval.
- Prior corticosteroid therapy within 14 days of first receipt of study drug.
- Treatment with any investigational agent within 28 days of first receipt of study drug.
- Acute or chronic infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- History of clinically significant bowel disease including abdominal fistula, gastro-intestinal perforation, and diverticulitis.
- Major surgery within 28 days of first receipt of study drug.
- Pregnant or lactating women
- Altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Activity of CH5132799 Administered Orally as a Monotherapy in Patients With Advanced Solid Tumors
This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- CH5132799
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH5132799Drug
| Study group | Role | What they receive |
|---|---|---|
| CH5132799 | Experimental | Not described Receives: Drug: CH5132799 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities
Measured: Upon completion of the study
Preliminary anti-tumour activity
Measured: Upon completion of the study
Secondary outcomes (2)
To determine the pharmacokinetics of CH5132799
Measured: Upon completion of the study
To characterise the pharmacodynamic effect of CH5132799 in surrogate tissues
Measured: Upon completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222546
- Sponsor's protocol ID
- PA-001EU
- Status last verified
- Jun 2014
- First submitted
- 14 Oct 2010
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Activity of CH5132799 Administered Orally as a Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01222546
- Acronym / sponsor ID
- PA-001EU
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chugai Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Oct 2010 (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.
This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CH5132799 | Experimental | Drug: CH5132799 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provision of signed written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Life expectancy of ≥ 12 weeks.
Key exclusion criteria (18 listed)
- History of allergic reactions attributed to components of the formulated product.
- Inability to swallow oral medications or impaired gastrointestinal absorption due to active inflammatory bowel disease.
- Known Central Nervous System (CNS) metastases or leptomeningeal metastases will be eligible only if it could be radiologically demonstrated that there is no CNS disease progression during the 3 months prior to the study
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled hypertension
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 |
|---|---|---|
| CH5132799 | Drug | CH5132799 |
Primary outcome
Occurrence of dose limiting toxicities
Time frame: Upon completion of the study
Preliminary anti-tumour activity
Time frame: Upon completion of the study
2 secondary outcomes
To determine the pharmacokinetics of CH5132799
Time frame: Upon completion of the study
To characterise the pharmacodynamic effect of CH5132799 in surrogate tissues
Time frame: Upon completion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CH5132799 in people with Solid Tumors, run by Chugai Pharma Europe Ltd. at 1 site 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 16 inclusion and 18 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: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of dose limiting toxicities (time frame: Upon completion of the study). 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 23 Jun 2014.