Last updated: October 20, 2021
Sponsor: Abbisko Therapeutics Co, Ltd
Overall Status: Active - Recruiting
Phase
1/2
Condition
Carcinoma
Urothelial Carcinoma
Treatment
N/AClinical Study ID
NCT05086666
ABSK091-201
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged ≥ 25, both male and female;
- Patients with histologically confirmed, surgically unresectable locally advanced ormetastatic uroepithelial carcinoma that may be accompanied by other histologicdifferentiation (<50% of the total, including adenoid, squamous, or more aggressivesarcomatoid/micropapillary differentiation)
- ECOG PS (performance status) score of 0-2;
- Expected survival of ≥ 3 months;
- Acceptable organ functions satisfy the following laboratory test requirements, and thetest results should be obtained within 14 d prior to the first dose for studytreatment (no transfusion of blood or blood products within 14 d prior to the bloodtest and no correction with bone marrow hematopoietic stimulating factors):
- Female or male subjects of childbearing potential must agree to take medicallyapproved measures for contraception during and for 6 months after the end of the studytreatment; female subjects of childbearing potential must have a negative blood β-HCGtest within 7 d prior to first dosing and must be non-lactating;
- Subjects must voluntarily participate in this clinical trial, understand the studyprocedures and be able to sign an informed consent form in writing.
Exclusion
Exclusion Criteria:
- Known to be allergic to AZD4547 tablets or constituents;
- Subjects have previously received selective FGFR inhibitors (in the case ofmulti-target inhibitors including FGFR, it is required to discuss with the sponsor todecide whether they can be included);
- There have been other malignancies requiring treatment in the past 2 years (except forcured skin cancer, cervical carcinoma in situ, basal cell carcinoma, focal prostatecancer with a Gleason score of 6, and focal prostate cancer at low risk of recurrencewith a Gleason score of 3+4 and treated for more than 6 months at screening);
- There are unstable (those who clinically/radiologically stable for at least 4 weeksprior to signing the ICF and requiring no long-term corticosteroid treatment may beenrolled) or symptomatic CNS metastases (other than pia mater metastases), or piamater metastases of any condition;
- The investigator determines that there are significant factors influencing oral drugabsorption, such as inability to swallow complete pills, any type of uncontrollablenausea and vomiting, residual stomach dysfunction after total gastrectomy or subtotalgastrectomy, short bowel syndrome after small bowel resection, active diarrhea orirritable bowel syndrome requiring medical attention;
- Time to the end of prior other antineoplastic therapy from the time of receiving thefirst dose of the study drug: < 4 weeks for major surgical operations (allowingpalliative treatment for localized lesions), radiation therapy (> 30% bone marrowexposure), conventional chemotherapy, targeted therapy, immunotherapy, otherinterventional clinical study therapy (< 6 weeks for treatment with nitrosoureas ormitomycin); < 2 weeks or 5 drug half-lives (whichever is shorter) for endocrinetherapy, herbal or Chinese medicinal preparations with antitumor indications, orherbal or Chinese medicinal preparations with adjuvant antitumor therapeutic effects;
- Patients not recovered to ≤ CTCAE Grade 1 from reversible adverse events due to priorantineoplastic therapy (except for toxicities of no clinical significance such asalopecia, skin hypopigmentation, etc.);
- There is a persistent increase in serum phosphorus levels (> ULN) requiring treatmentcontrol within 14 d prior to the first dose for study treatment;
- Patients are using, or have used, within 14 d prior to the first dose of studytreatment, the following drugs/foods: CYP3A4, 2D6 strong inhibitors or inducers (including grapefruit juice, grapefruit hybrids, pomegranate, star fruit, pomelo,Seville oranges and juice or other processed products);
- There are uncontrolled cardiovascular diseases or a history thereof
- Patients are taking medications during screening that may cause prolonged QTc intervalor torsades de pointes (see section 5.4.3). Patients should discontinue such drugs forat least 5 d or 5 half-lives of the drug (whichever is longer) prior to the first dosefor study treatment;
- There are severe untreated skin/mucosal ulcers, chronic ulcers of the lowerextremities, known gastric ulcers or incisions;
- There is human immunodeficiency virus (HIV) infection (positive serologic test for HIVantibodies); active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection (excluding those with a previous history of hepatitis C but a negative PCR test forhepatitis C virus during the screening period, or those with only positive hepatitis Bvirus surface antibodies on the hepatitis B test, or positive hepatitis B virussurface antigen but HBV DNA <1000 IU/mL);
- There are any abnormal corneal or retinal changes during screening that may increasethe risk of ocular toxicity
- Any other medical (e.g., respiratory, metabolic, infectious, immune, congenital,endocrine, or central nervous system disorders), psychiatric, or social factors thatmay affect the subject's rights, safety, or the subject's ability to sign the informedconsent form, cooperate, participate in the clinical study, or affect theinterpretation of the study results as determined by the investigator.
Study Design
Total Participants: 108
Study Start date:
June 03, 2021
Estimated Completion Date:
May 27, 2024
Study Description
Connect with a study center
Fudan University Cancer Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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