Solid TumorsPhase 1NCT00970411
Study of KRN951 in Patients With Solid Tumors
A Phase 1 study testing KRN951 in people with Solid Tumors, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- KRN951
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2009to Apr 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Solid tumors to be unresponsive to, or untreatable by standard therapies
- ≥ three-month life expectancy
- Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2
Who cannot join
- Hematologic abnormality
- Myocardial infarction or clinically symptomatic left ventricular failure
- Active hypertension or controllable hypertension more than 3 antihypertensive medications
- Symptomatic CNS metastasis
- Unhealed wounds
- Active infections
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- Hepatic or renal functional disorder
- Any of the HBs antigen, HCV antibody and HIV antibody positivity
- Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug
- Pregnant or lactating women
- Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.
- Conditions
- Solid Tumors
- Being tested
- KRN951
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRN951Drug
Orally once daily administration
| Study group | Role | What they receive |
|---|---|---|
| KRN951 | Experimental | Not described Receives: Drug: KRN951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.
To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment.
Secondary outcomes (2)
To determine the pharmacokinetics of KRN951 in serum
To describe biological and clinical anti-tumor activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2016
- Study completionApr 2016
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.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970411
- Sponsor's protocol ID
- KRN951-001
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2009
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00970411
- Acronym / sponsor ID
- KRN951-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Sep 2009 (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 assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRN951 | Experimental | Drug: KRN951 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Solid tumors to be unresponsive to, or untreatable by standard therapies
- ≥ three-month life expectancy
- Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2
Key exclusion criteria (11 listed)
- Hematologic abnormality
- Myocardial infarction or clinically symptomatic left ventricular failure
- Active hypertension or controllable hypertension more than 3 antihypertensive medications
- Symptomatic CNS metastasis
- Unhealed wounds
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 |
|---|---|---|
| KRN951Orally once daily administration | Drug | KRN951 |
Primary outcome
To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.
To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment.
2 secondary outcomes
To determine the pharmacokinetics of KRN951 in serum
To describe biological and clinical anti-tumor activity
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 5 Jan 2017.
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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 KRN951 in people with Solid Tumors, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 11 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 5 Jan 2017. 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 Japan. 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?
To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.. 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 5 Jan 2017.