NeoplasmsPhase 1NCT01682473
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
A Phase 1 study testing ZSTK474 in people with Neoplasms, run by Zenyaku Kogyo Co., Ltd. at 2 sites in Japan.
Trial summary
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- ZSTK474
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesJapan
- Study dates
- 20 Sep 2012to 20 Apr 2015
- 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
- Japanese males or females >= 20 years old
- Advanced (metastatic or unresectable) solid tumor
- ECOG performance status score of 0 or 1 and expected survival >12 weeks
- Recovered from hematological toxicities of prior cancer therapies
Who cannot join
- Previous treatment with PI3K inhibitor
- Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
- Other investigational agent within previous 4 weeks
- Participating in another clinical study
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
National Cancer Center Hospital East
Kashiwa, Chiba
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
About this study
Official title: A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
Read the detailed description
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).
- Conditions
- Neoplasms
- Being tested
- ZSTK474
- Keywords
- PI3K inhibitor, clinical trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSTK474Drug
Two arms, each with serial cohorts receiving escalating doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 5/2 Dosing | Experimental | Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug. Receives: Drug: ZSTK474 |
| Arm 2: 21/7 Dosing | Experimental | Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug. Receives: Drug: ZSTK474 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities
Measured: 28 days
Secondary outcomes (1)
Pharmacokinetics (Cmax, tmax, t½, AUC)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study start20 Sep 2012
- Primary completion2 Apr 2015
- Study completion20 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenyaku Kogyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshihiko Doi, MD, PhD, Principal investigator, National Cancer Center Hospital EastShunji Takahashi, MD, Principal investigator, The Cancer Institute Hospital of JFCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682473
- Sponsor's protocol ID
- ZSTK474-201
- Status last verified
- Jul 2017
- First submitted
- 4 Sep 2012
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01682473
- Acronym / sponsor ID
- ZSTK474-201
- Conditions
- Neoplasms
- Keywords
- PI3K inhibitor, clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zenyaku Kogyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2012 (actual)
- Primary completion
- 2 Apr 2015 (actual)
- Study completion
- 20 Apr 2015 (actual)
- First posted
- 11 Sep 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.
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
Detailed description
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 5/2 Dosing | Experimental | Drug: ZSTK474Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug. |
| Arm 2: 21/7 Dosing | Experimental | Drug: ZSTK474Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese males or females >= 20 years old
- Advanced (metastatic or unresectable) solid tumor
- ECOG performance status score of 0 or 1 and expected survival >12 weeks
- Recovered from hematological toxicities of prior cancer therapies
Key exclusion criteria (4 listed)
- Previous treatment with PI3K inhibitor
- Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
- Other investigational agent within previous 4 weeks
- Participating in another clinical study
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 |
|---|---|---|
| ZSTK474Two arms, each with serial cohorts receiving escalating doses. | Drug | Arm 1: 5/2 Dosing, Arm 2: 21/7 Dosing |
Primary outcome
Number of participants with dose-limiting toxicities
Time frame: 28 days
1 secondary outcome
Pharmacokinetics (Cmax, tmax, t½, AUC)
Time frame: 28 days
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 6 Jul 2017.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Toshihiko Doi, MD, PhD principal investigator
National Cancer Center Hospital East
Shunji Takahashi, MD principal investigator
The Cancer Institute Hospital of JFCR
2 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 ZSTK474 in people with Neoplasms, run by Zenyaku Kogyo Co., Ltd. at 2 sites 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 4 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of participants with dose-limiting toxicities (time frame: 28 days). 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 6 Jul 2017.