NeoplasmsPhase 1NCT01280487
A Safety Study of Oral ZSTK474 in Patients With Cancer
A Phase 1 study testing ZSTK474 in people with Neoplasms, run by Zenyaku Kogyo Co., Ltd. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase (PI3K) inhibitor, in subjects with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 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
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2011to Jan 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
- Male or females ≥18 years of age;
- Histologically-confirmed advanced (metastatic or unresectable) solid tumor - for which available therapy is not effective;
- ECOG performance status score of ≤2 and an expected survival of >8 weeks;
- Recovered from the toxicities of prior chemotherapy, radiotherapy, and other cancer therapies; all toxicities must be determined to be below Grade 2 (assessed using the NCI CTCAE v4.0).
- Adequate blood counts with a hemoglobin (Hgb) of ≥9.0 mg/dL, absolute neutrophil count (ANC) >1,500/mm3, and platelets ≥100,000/mm3 (all without transfusion support);
- Subjects who are willing and able to provide written informed consent.
- In the expanded cohort at the MTD only: Subjects must be willing to undergo mandatory biopsies of tumor tissue twice during the first cycle (before and during dosing) and must have tumor tissue in a location accessible to incisional biopsy of a superficial lesion or percutaneous core needle biopsy on an outpatient basis without undue risk to the subject.
Who cannot join
- Women who are pregnant or breastfeeding;
- Men or women of reproductive potential who are not willing to use acceptable means of contraception while on study drug and for an additional 90 days after the last dose of study drug;
- Body Mass Index (BMI) is ≥30 kg/m2;
- Have primary central nervous system (CNS) tumors or untreated/uncontrolled CNS metastases; Note: Subjects with stable/controlled CNS metastases may be enrolled (i.e., if CNS lesions have been stable in size for at least one month and the subject is off steroid and anti-convulsants).
- Have received any investigational interventional agents within the 4 weeks prior to the start of dosing with ZSTK474;
- Are receiving concurrent anti-tumor chemotherapy, radiotherapy, or immunotherapy - or have received any of these non-investigational agents within the previous 4 weeks or 5-half-lives (whichever is longer) prior to the start of dosing with ZSTK474;
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- Are not able or willing to comply with the study procedures, including the study visit schedule;
- Have previously been treated with a phosphatidylinositol 3 kinase (PI3K) inhibitor;
- Have serious or significant intercurrent illnesses or underlying diseases, such as:
- Diabetes
- Gastrointestinal disorder
- Hepatic: AST or ALT >2.5 x ULN (or >5.0 x ULN with liver metastases) or serum bilirubin >1.5 x ULN;
- Renal (acute or chronic renal disease or eGFR <55 mL/min)
- Cardiovascular:
- Uncontrolled hypertension or blood pressure >140/90 mmHg;
- Symptomatic congestive heart failure;
- Myocardial infarction within the past 6 months;
- Unstable angina pectoris;
- Cardiac arrhythmia;
- Congenital long QT syndrome;
- QTc >450 msec for men or >470 msec for women.
- Other:
- Known diagnosis of HIV infection;
- Other ongoing or active infections;
- Psychiatric illness, substance abuse or social situation that would preclude study compliance.
- Other serious concurrent illness that would preclude assessment of drug effect;
- PT/PTT)/APTT/INR >ULN for subjects not on anti-coagulants; INR > 1.5 x ULN for subjects on low dose warfarin.
- Current treatment with the following drugs:
- any anti-seizure medications;
- therapeutic anti-coagulant doses of warfarin.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts
Fox Chase Cancer Center
Philadelphia, Pennsylvania
Washington University
St Louis, Missouri
About this study
Official title: A Phase 1b, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Daily Oral Doses of ZSTK474 in Subjects With Advanced Solid Malignancies
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase (PI3K) inhibitor, in subjects with advanced solid malignancies.
- Conditions
- Neoplasms
- Being tested
- ZSTK474
- Keywords
- ZSTK474, PI3K inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSTK474Drug
Daily oral dosing for 21 days each cycle
| Study group | Role | What they receive |
|---|---|---|
| Oral ZSTK474 | Experimental | Daily oral dosing for 21 days per cycle Receives: Drug: ZSTK474 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 21 days
Secondary outcomes (1)
Pharmacokinetics
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionJan 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenyaku Kogyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Lockhart, MD, Principal investigator, Washington University School of MedicineAnthony Olszanski, MD, Principal investigator, Fox Chase Cancer CenterGeoffrey Shapiro, MD PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280487
- Sponsor's protocol ID
- ZSTK474-101
- Status last verified
- Jan 2015
- First submitted
- 18 Jan 2011
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Daily Oral Doses of ZSTK474 in Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01280487
- Acronym / sponsor ID
- ZSTK474-101
- Conditions
- Neoplasms
- Keywords
- ZSTK474, PI3K inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zenyaku Kogyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Jan 2011 (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 evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase (PI3K) inhibitor, in subjects with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral ZSTK474 | Experimental | Drug: ZSTK474Daily oral dosing for 21 days per cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or females ≥18 years of age;
- Histologically-confirmed advanced (metastatic or unresectable) solid tumor - for which available therapy is not effective;
- ECOG performance status score of ≤2 and an expected survival of >8 weeks;
- Recovered from the toxicities of prior chemotherapy, radiotherapy, and other cancer therapies; all toxicities must be determined to be below Grade 2 (assessed using the NCI CTCAE v4.0).
- Adequate blood counts with a hemoglobin (Hgb) of ≥9.0 mg/dL, absolute neutrophil count (ANC) >1,500/mm3, and platelets ≥100,000/mm3 (all without transfusion support);
Key exclusion criteria (30 listed)
- Women who are pregnant or breastfeeding;
- Men or women of reproductive potential who are not willing to use acceptable means of contraception while on study drug and for an additional 90 days after the last dose of study drug;
- Body Mass Index (BMI) is ≥30 kg/m2;
- Have primary central nervous system (CNS) tumors or untreated/uncontrolled CNS metastases; Note: Subjects with stable/controlled CNS metastases may be enrolled (i.e., if CNS lesions have been stable in size for at least one month and the subject is off steroid and anti-convulsants).
- Have received any investigational interventional agents within the 4 weeks prior to the start of dosing with ZSTK474;
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 |
|---|---|---|
| ZSTK474Daily oral dosing for 21 days each cycle | Drug | Oral ZSTK474 |
Primary outcome
Maximum tolerated dose
Time frame: 21 days
1 secondary outcome
Pharmacokinetics
Time frame: 21 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 16 Jan 2015.
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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.
Craig Lockhart, MD principal investigator
Washington University School of Medicine
Anthony Olszanski, MD principal investigator
Fox Chase Cancer Center
Geoffrey Shapiro, MD PhD principal investigator
Dana-Farber Cancer Institute
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 ZSTK474 in people with Neoplasms, run by Zenyaku Kogyo Co., Ltd. at 3 sites 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 30 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 16 Jan 2015. 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 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?
Maximum tolerated dose (time frame: 21 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 16 Jan 2015.