CancerPhase 1NCT00542958
Study of NK012 in Patients With Refractory Solid Tumors
A Phase 1 study testing NK012 in people with Cancer, run by Nippon Kayaku Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- NK012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2011
- 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
- Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority
- Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist
- Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
- Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1
- 18 years of age or older
- Adequate kidney, liver, and bone marrow function
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier
- Receiving any other investigational agent
- History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week
- History of allergic reactions attributed to compounds of similar chemical composition to NK012
- Concurrent serious infections (i.e., requiring an intravenous antibiotic)
- Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements
- Significant cardiac disease
- History of serious ventricular arrhythmia
- Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors
Read the detailed description
This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group.
- Conditions
- Cancer
- Being tested
- NK012
- Keywords
- Cancer, Refractory solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK012Drug
9.0, 12.0, 16.0, 21.0, 28.0 mg/m^2, and to be determined. Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| NK012 | Experimental | This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group. Dose-escalation in each patient population will proceed according to the predefined dose level.
For UGT1A1*28 (wt/wt and wt/*28) patients, at least 3 evaluable patients will be treated at each dose level.
UGT1A1 homozygous (*28/*28) patients will be treated at 50% of the current dose level.
Patients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study. Receives: Drug: NK012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Measured: At the end of Cycle 1 (each cycle is 21 days)
Maximum tolerated dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Measured: At the end of Cycle 1 (each cycle is 21 days)
Recommended phase II dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
After MTD was determined, the administration schedule was changed to every 28 days per cycle, considering patient safety.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (8)
Toxicity profile of NK012 in all patients
Measured: Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.
Antitumor activity of NK012 according to RECIST criteria in all patients
Overall response will be evaluated every 2 cycles
Measured: Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.
Pharmacokinetic parameter: Maximum concentration (Cmax)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Time to reach the maximum concentration (Tmax)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Terminal-phase half life (T1/2z)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Area under the concentration-time curve for time zero to infinity (AUCinf)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Total body clearance (CLtot)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Volume of distribution at steady-state (Vss)
Measured: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard A. Burris, III, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542958
- Sponsor's protocol ID
- N06-10089
- Status last verified
- Mar 2013
- First submitted
- 11 Oct 2007
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00542958
- Acronym / sponsor ID
- N06-10089
- Conditions
- Cancer
- Keywords
- Cancer, Refractory solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Oct 2007 (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 determine whether NK012 is safe and effective in the treatment of refractory solid tumors
Detailed description
This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK012 | Experimental | Drug: NK012This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group. Dose-escalation in each patient population will proceed according to the predefined dose level. For UGT1A1*28 (wt/wt and wt/*28) patients, at least 3 evaluable patients will be treated at each dose level. UGT1A1 homozygous (*28/*28) patients will be treated at 50% of the current dose level. Patients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority
- Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist
- Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
- Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1
- 18 years of age or older
Key exclusion criteria (10 listed)
- Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier
- Receiving any other investigational agent
- History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week
- History of allergic reactions attributed to compounds of similar chemical composition to NK012
- Concurrent serious infections (i.e., requiring an intravenous antibiotic)
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 |
|---|---|---|
| NK0129.0, 12.0, 16.0, 21.0, 28.0 mg/m^2, and to be determined. Intravenous infusion | Drug | NK012 |
Primary outcome
Dose-limiting toxicity of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Maximum tolerated dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Recommended phase II dose of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
Time frame: At the end of Cycle 1 (each cycle is 28 days)
After MTD was determined, the administration schedule was changed to every 28 days per cycle, considering patient safety.
8 secondary outcomes
Toxicity profile of NK012 in all patients
Time frame: Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.
Antitumor activity of NK012 according to RECIST criteria in all patients
Time frame: Through study completion (6 cycles of study drug administration period and 30 days of follow-up period), an average of 5 months for 21-day cycle or 6 months for 28-days cycle.
Pharmacokinetic parameter: Maximum concentration (Cmax)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Time to reach the maximum concentration (Tmax)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Terminal-phase half life (T1/2z)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Area under the concentration-time curve for time zero to infinity (AUCinf)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Total body clearance (CLtot)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
Pharmacokinetic parameter: Volume of distribution at steady-state (Vss)
Time frame: Sampling during Cycle 1 (first 3 weeks) and up to Day 3 of Cycle 2, if applicable, total 24 days for 21-days cycle or 31 days for 28-day cycle.
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 28 Oct 2019.
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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.
Howard A. Burris, III, MD principal investigator
SCRI Development Innovations, LLC
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 NK012 in people with Cancer, run by Nippon Kayaku Co., Ltd. at 1 site in United States.
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 7 inclusion and 10 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 28 Oct 2019. 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 States. 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?
Dose-limiting toxicity of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype (time frame: At the end of Cycle 1 (each cycle is 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 28 Oct 2019.