Solid TumorPhase 1NCT03583125
Study of EOC317 in Chinese Patients With Advanced Solid Tumors
A Phase 1 study testing EOC317 in people with Solid Tumor, run by Taizhou EOC Pharma Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-arm phase 1, dose escalation study of EOC317 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 Tumor
- What is being tested?
- EOC317
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2018to 29 Nov 2020
- 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
- Patients is able to understand and willing to sign a written informed consent.
- Patients is willing to complete the study procedure and follow-up examinations.
- Male or female patients, 18 years old and above.
- Dose-escalation phase: patients with histopathologically or cytopathologically confirmed advanced malignant solid tumors, including bladder cancer, cholangiocarcinoma, gastric cancer, breast cancer; dose-expansion phase: patients with histopathologically or cytopathologically confirmed advanced urothelial cancer, cholangiocarcinoma, and hepatocellular carcinoma or other advanced solid tumor with confirmed FGFR alterations.
- Patients who have disease progression after previous standard of care therapy, or are unable to tolerate standard of care therapy, or have no available standard of care therapy.
- Dose-escalation phase: measurable or unmeasurable lesion is acceptable; dose-expansion phase: at least one measurable lesion.
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- In accordance with the response evaluation criteria in solid tumors (RECIST v1.1), measurable lesion is defined as the lesion with the longest diameter ≥10 mm and thickness scanned ≤5mm in CT or MRI. For lymph node lesion, its minor axis must be ≥15mm.
- ECOG score is 0-1.
- Expected survival is longer than 3 months.
- No serious hematological, hepatic, or renal abnormality, in accordance with the results of the following laboratory tests:
- Hematology: neutrophil ≥1.5x10^9/L, platelet ≥75x10^9/L, hemoglobin ≥90 g/L;
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x3.0; alkaline phosphatase (ALP) ≤ upper limit of normal x2.5; total bilirubin (TBIL) ≤upper limit of normal x1.5; If there is a liver tumor, hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x5.0; If there is bone metastasis or a liver tumor, alkaline phosphatase (ALP) ≤ upper limit of normal x5.0;
- Renal function: the creatinine clearance calculated by the Cockcroft-Gault formula must be ≥ 50 mL/min.
- All the adverse events is recovered to ≤ CTCAE grade 1 after previous systemic anti-tumor therapy (except alopecia and leukodermia; stable or ≤ CTCAE grade 2 neuropathy induced by previous anti-tumor therapy).
- Effective contraceptive measures during the treatment and within 6 months after the last dose for male and female patients.
- Dose-escalation phase: collection of tumor biopsy samples will be optional; dose-expansion phase: non-optional collection of tumor biopsy samples if the FGFR alteration is unknown during screening period;
- Dose-expansion phase: liver function rating Child-Pugh grade A or grade B ( score ≥7);
- Blood pressure is effectively controlled using 0 or 1 antihypertensive drugs, (blood pressure ≤150/90 mmHg), without replacing antihypertensive drugs within 1 week before day 1 of cycle 1;
Who cannot join
- Previous use of the drug against FGFR pathway.
- Having other malignant tumors other than the tumor treated in the study (exceptions: the malignant tumors cured with no recurrence within three years before enrollment in the study; completely resected basal cell and squamous cell carcinoma of skin; completely resected carcinoma in situ of any type).
- Invasion of original lesion to central nervous system (CNS) with symptoms, which is unstable and requires high-dose steroid (≥10 mg Dexamethasone or equivalent dose) to control it.
- Clinically significant laboratory calcium/phosphorus abnormalities in patients even after medical intervention before the first dose of study treatment, or in association with parathyroid disorder or tumor lysis syndrome.
- Ophthalmic diseases known to affect visual sensitivity, e.g., retinal/corneal/lens lesions, severe glaucoma, et al.;
- Active infection requiring systemic treatment (e.g., virus, bacteria, or fungus).
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- Receiving the following concomitant therapies prior to the start use of EOC317:
- Use of the drugs that can prolong QT interval and/or have the risk of torsades de pointes (TdP) within 7 days after the first dose, for example, quinidine, flecainide, Ibutilide;
- Use of amiodarone within 90 days prior to the first dose.
- Cardiac impairment or clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident/stroke (within 6 months before enrollment);
- Myocardial infarction (within 6 months before enrollment);
- Unstable angina pectoris, congestive heart failure (New York Heart Association classification ≥grade 2) or serious arrhythmia requiring drug therapy (including prolonged QT interval/QTc>470 ms, pacemaker implantation); left ventricular ejection fraction (LVEF) <50% in echocardiography.
- History of active hemorrhage or gastrointestinal perforation risk in recent four weeks, or unhealed wound in recent surgery.
- Receiving the following therapies within the time period specified below prior to the first dose :
- Anticancer therapy ≤ 4 weeks;
- Receiving other clinical trial drugs ≤ 4 weeks or ≤ 5 known half-lives (whichever comes later); major surgery ≤4 weeks prior to the start use of investigational product.
- Long-term use of steroid, and daily use of ≥10 mg prednisone or equivalent dose (e.g., ≥0.75mg dexamethasone).
- Past history of chronic diarrhea ≥ three years or presence of diarrhea prior to the EOC317 treatment.
- HBsAg is positive and HBV DNA copies> normal range of detection; positive hepatitis C antibody or HCV RNA; in patients with hepatocellular carcinoma and cholangiocarcinoma, HBV tests show HBsAg-positive or HbcAb-positive, and HBV DNA ≥10^4 copies/ml or ≥2000 IU/ml (patients with undetectable HBV DNA after 2 weeks of standard antiviral therapy can be enrolled), HCV RNA >10^3 copies/ml (patients with undetectable HCV RNA after 2 weeks of standard antiviral therapy can be enrolled); HbsAg and anti-HCV are both positive at the same time;
- History of human immunodeficiency virus infection, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- Known alcohol and/or drug addiction.
- Previous history of neurological or psychiatric/behavioral disorder, e.g., epilepsy, history of poor compliance.
- Female patients with positive results of pregnancy test or who are currently lactating
- Patients who are not suitable for participation in this trial for any other reasons in investigators' judgement.
- Dose-expansion phase: patients with hepatic encephalopathy; moderate or severe ascites that could not be alleviated or requiring therapeutic abdominal puncture or drainage (confirmed by B-ultrasound or CT scan within 1 week before randomization).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Hongming Pan, M.D
About this study
Official title: A Phase 1 Dose Escalation Study of EOC317 in Chinese Patients With Advanced Solid Tumors
This is an open-label, single-arm phase 1, dose escalation study of EOC317 in patients with advanced solid tumors.
Read the detailed description
This is an open-label, single-arm, phase 1, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of EOC317 in patients with advanced solid tumors.
The study comprises a dose-escalation phase and a dose-expansion phase.
- Dose-escalation: using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of EOC317 at 5, 10, 20, 30, 45, 60 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended dose (RDE) for the dose expansion phase.
- Dose-expansion: based on PK profile in the dose escalation phase, the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the RDE for EOC317 in patients with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- EOC317
- Keywords
- bladder cancer, cholangiocarcinoma, gastric cancer, breast cancer, hepatocellular carcinoma
- Medical subject headings
- Urinary Bladder Neoplasms, Cholangiocarcinoma, Stomach Neoplasms, Breast Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOC317Drug
tablet(s) PO
| Study group | Role | What they receive |
|---|---|---|
| EOC 317 | Experimental | Dose-escalation: 20 subjects will be given EOC 317 PO in increasing doses from 5 mg up to 60 mg or higher doses. One dose on Day 1, paused for 2 days, and then daily from Day 4 to Day 24.
Dose-expansion: 120 subjects will be given EOC 317 PO QD from Day 1 to Day 21. Receives: Drug: EOC317 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
DLT and its incidence at each dose level
Measured: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 months
Secondary outcomes (8)
ORR
Overall Objective Response Rate
Measured: up to 24 months
DCR
Disease Control Rate
Measured: up to 24 months
DOR
Duration of Response
Measured: up to 24 months
PFS
Progression-free Survival
Measured: up to 24 months
Cmax
Maximum Plasma Concentration
Measured: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
Tmax
Time at which maximum plasma concentration was observed.
Measured: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
AUC 0-inf
Area under the plasma concentration-time curve from time zero to infinity.
Measured: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
T1/2
Elimination Half-life
Measured: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start29 May 2018
- Primary completion29 Feb 2020 (estimated)
- Study completion29 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongming Pan, M.D., Study chair, Sir Run Run Shaw Hospital, Zhejiang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583125
- Sponsor's protocol ID
- EOC317X1101
- Status last verified
- May 2019
- First submitted
- 1 Jun 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of EOC317 in Chinese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03583125
- Acronym / sponsor ID
- EOC317X1101
- Conditions
- Solid Tumor
- Keywords
- bladder cancer, cholangiocarcinoma, gastric cancer, breast cancer, hepatocellular carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 29 Nov 2020 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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, single-arm phase 1, dose escalation study of EOC317 in patients with advanced solid tumors.
Detailed description
This is an open-label, single-arm, phase 1, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of EOC317 in patients with advanced solid tumors.
The study comprises a dose-escalation phase and a dose-expansion phase.
- Dose-escalation: using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of EOC317 at 5, 10, 20, 30, 45, 60 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended dose (RDE) for the dose expansion phase.
- Dose-expansion: based on PK profile in the dose escalation phase, the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the RDE for EOC317 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 |
|---|---|---|
| EOC 317 | Experimental | Drug: EOC317Dose-escalation: 20 subjects will be given EOC 317 PO in increasing doses from 5 mg up to 60 mg or higher doses. One dose on Day 1, paused for 2 days, and then daily from Day 4 to Day 24. Dose-expansion: 120 subjects will be given EOC 317 PO QD from Day 1 to Day 21. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients is able to understand and willing to sign a written informed consent.
- Patients is willing to complete the study procedure and follow-up examinations.
- Male or female patients, 18 years old and above.
- Dose-escalation phase: patients with histopathologically or cytopathologically confirmed advanced malignant solid tumors, including bladder cancer, cholangiocarcinoma, gastric cancer, breast cancer; dose-expansion phase: patients with histopathologically or cytopathologically confirmed advanced urothelial cancer, cholangiocarcinoma, and hepatocellular carcinoma or other advanced solid tumor with confirmed FGFR alterations.
- Patients who have disease progression after previous standard of care therapy, or are unable to tolerate standard of care therapy, or have no available standard of care therapy.
Key exclusion criteria (26 listed)
- Previous use of the drug against FGFR pathway.
- Having other malignant tumors other than the tumor treated in the study (exceptions: the malignant tumors cured with no recurrence within three years before enrollment in the study; completely resected basal cell and squamous cell carcinoma of skin; completely resected carcinoma in situ of any type).
- Invasion of original lesion to central nervous system (CNS) with symptoms, which is unstable and requires high-dose steroid (≥10 mg Dexamethasone or equivalent dose) to control it.
- Clinically significant laboratory calcium/phosphorus abnormalities in patients even after medical intervention before the first dose of study treatment, or in association with parathyroid disorder or tumor lysis syndrome.
- Ophthalmic diseases known to affect visual sensitivity, e.g., retinal/corneal/lens lesions, severe glaucoma, et al.;
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 |
|---|---|---|
| EOC317tablet(s) PO | Drug | EOC 317 |
Primary outcome
DLT
Time frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 months
DLT and its incidence at each dose level
8 secondary outcomes
ORR
Time frame: up to 24 months
DCR
Time frame: up to 24 months
DOR
Time frame: up to 24 months
PFS
Time frame: up to 24 months
Cmax
Time frame: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
Tmax
Time frame: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
AUC 0-inf
Time frame: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
T1/2
Time frame: Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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.
Hongming Pan, M.D. study chair
Sir Run Run Shaw Hospital, Zhejiang, China
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 EOC317 in people with Solid Tumor, run by Taizhou EOC Pharma Co., Ltd. at 1 site in China.
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 18 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 11 Sep 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Echo Zhao, M.D. (+86-021-3175 7928, Echo.Zhao@eocpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 months). 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 11 Sep 2019.