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Clinical Study of ICP-192 in Solid Tumors Patients

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ClinicalTrials.gov Identifier: NCT03758664
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary:
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: ICP-192 Phase 1

Detailed Description:
The study consisted of a screening period, a treatment period with 21 days of repeated treatment per cycle (duration treatment with ICP-192), and a follow-up period (28 days after last dose). The recruited patients receive a single dose on day 1, then after a 3-day washout period, repeated dosing will be followed. The starting dose is 2 mg, QD, and dose escalation will follow accelerated titration and modified 3+3 dose-finding schema. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (21-day cycle).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-192 in Patients With Advanced Solid Malignancies
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: ICP-192
The initial dose of ICP-192 is 2 mg, QD, and dose escalation schedule may be modified based on the safety and PK from the previous dose. Tentatively seven dose levels will be evaluated.
Drug: ICP-192
Drug: ICP-192 Dose levels will be escalated following a modified 3+3 dose escalation scheme




Primary Outcome Measures :
  1. Adverse events [ Time Frame: From date of first scheduled visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Adverse events graded by CTCAE v4.03 as a measurement of the safety and tolerability profile of ICP-192


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study ]
    Single dose PK parameters include the peak plasma concentration (Cmax)

  2. AUC [ Time Frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study ]
    Area under the plasma concentration vs. time curve (AUC)

  3. Apparent half-life for designated elimination phases (t½) [ Time Frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study ]
    will be measured and calculated with noncompartmental analysis using WinNonlin

  4. Food effect [ Time Frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study ]
    ICP-192 concentrations in plasma and urine after dosing in fed and fasted condition



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 Years and older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • At least one evaluable disease according to RECIST1.1
  • Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
  • Life expectancy ≥ 3 months
  • adequate bone marrow, liver, renal, and cardiovascular function Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Hemoglobin (Hgb) ≥ 9.0 g/dL Total bilirubin ≤ 1.5 × upper limit of normal (ULN) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 x ULN for subjects with liver metastases) Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 70 mL/min INR or PT ≤1.5×ULN

Exclusion Criteria:

  • Previous treatment with FGFR inhibitors or antibodies.
  • Anti-cancer therapy, such as chemotherapy (except for oral fluorouracil), immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-192, oral fluorouracil agents within two weeks of the first dose of ICP-192.
  • Major surgery within 6 weeks of the first dose of ICP-192.
  • Blood phosphate persistently above ULN with intervene therapy within two weeks of the first dose of ICP-192.
  • Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-192.
  • Central nervous system (CNS) metastasis
  • Current clinically significant cardiovascular disease including:
  • Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male)
  • Known active bleeding within 2 months of screening or 6 months of bleeding history.
  • According to the investigator's judgement, there are evidences of a serious or uncontrollable systemic disease (such as unstable or uncompensated respiratory, liver or kidney disease); or any unstable systemic disease (including active clinically serious infections, uncontrolled hypertension, liver and kidney or metabolic diseases)
  • History of interstitial pneumonia, deep vein thrombosis, pulmonary embolism. Stroke or intracranial hemorrhage within 6 months before the first dose of ICP-192.
  • History of organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Any corneal or retinal abnormalities that may increase ocular toxicity, including but not limited to:
  • History of central serous retinopathy (CSR) or retinal vein occlusion (RVO) disease or has related diseases;
  • Active age-related macular degeneration (AMD);
  • Diabetic retinopathy with macular edema;
  • Uncontrollable glaucoma;
  • Keratonosus, such as Keratitis, keratoconjunctivitis, keratopathy, corneal wear, inflammation or ulceration.
  • Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection
  • Any toxicities must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
  • Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
  • Investigators believe that the patients are not eligible for enrollment for the other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758664


Contacts
Contact: Jin Li, PhD 8621-38804518 ext 22132 lijin@csco.org.cn

Locations
China, Shanghai
Shanghai East Hospital
Shanghai, Shanghai, China, 200120
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
Principal Investigator: Jin Li, PhD Shanghai East Hospital

Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03758664     History of Changes
Other Study ID Numbers: ICP-CL-00301
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No