Study of EOC317 in Chinese Patients With Advanced Solid Tumors

NCT03583125 | Unknown Phase 1

• 1 other identifier: EOC317X1101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm phase 1, dose escalation study of EOC317 in patients with advanced solid tumors.

Conditions

Solid Tumor

Keywords

bladder cancer; cholangiocarcinoma; gastric cancer; breast cancer; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• DLT

  DLT and its incidence at each dose level

  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

  up to 24 months

• DCR

  up to 24 months

• DOR

  up to 24 months

• PFS

  up to 24 months

• Cmax

  Day1: pre-dose; after EOC317 administration 0.5h、1h、2h、3h、4h、6h、8h、12h, Day2：24h, Day3：48h

Other Outcomes (1)

• Pharmacodynamic Markers

  up to 24 months

Study Arms (1)

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.

Drug: EOC317

Interventions

EOC317 DRUG

tablet(s) PO

EOC 317

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \* 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.

You may not qualify if:

• 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).
• 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 :

Sponsors & Collaborators

• Taizhou EOC Pharma Co., Ltd.: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Cholangiocarcinoma; Stomach Neoplasms; Breast Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Liver Neoplasms; Liver Diseases

Study Officials

• Hongming Pan, M.D.

  Sir Run Run Shaw Hospital, Zhejiang, China

  STUDY CHAIR

Central Study Contacts

Echo Zhao, M.D.

CONTACT

+86-021-3175 7928; Echo.Zhao@eocpharma.com

Jie Li, M.S.

CONTACT

+86-021-3175 7928; jie.li@eocpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 11, 2018
• Study Start: May 29, 2018
• Primary Completion: February 29, 2020
• Study Completion: November 29, 2020
• Last Updated: September 11, 2019

Record last verified: 2019-05

Locations

CN (1)