- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05202236
A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Tao Zhang, Doctor
- Phone Number: 8618971656660
- Email: 1277577866@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥ 18 years old;
- With histologically or cytologically confirmed advanced metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction, or colorectal adenocarcinoma;
- Have at least one measurable lesion according to RECIST v1.1;
- With histologically confirmed FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.;
- With disease progression after a standard therapy (first-line therapy for gastric cancer; second-line therapy for colorectal cancer);
- No previous use of small molecule multi-target inhibitors targeting the FGFR pathway in the front-line therapy (including but not limited to anlotinib, lenvatinib, sorafenib, apatinib, etc.);
- ECOG physical performance status score of 0-1;
- Expected survival time > 3 months;
- For evidence of sufficient organ functions, the subjects shall meet the following laboratory parameters:
1) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without use of granulocyte colony stimulating factor in recent 14 days; 2) Platelet count ≥ 100 × 109/L without blood transfusion in recent 14 days; 3) Hemoglobin > 9 g/dL without blood transfusion or erythropoietin use in recent 14 days; 4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin > ULN, direct bilirubin ≤ ULN; 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN for patients with liver metastasis); 6) Blood creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 50 mL/min; 7) Good coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN (For subjects receiving an anticoagulant therapy, PT within the range proposed for the anticoagulant drug is acceptable); 10. Women of childbearing potential shall obtain a negative result in the urine or serum pregnancy test performed within 3 days before the first dose of the investigational drug (cycle 1, day 1). If the urine pregnancy test result cannot be identified as negative, a blood pregnancy test is needed. Women of non-childbearing potential are defined as those who have not had menses for at least 1 year or who have undergone surgical sterilization or hysterectomy; 11. All subjects at risk of conception (including their partners) shall use contraceptives with an annual failure rate of less than 1% throughout the entire treatment period up to 120 days after the last dose of the investigational drug (or 180 days after the last dose of the chemotherapy drug).
Exclusion Criteria:
- Diagnosed with malignant tumors other than gastric cancer and colorectal cancer within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
- Previously treated with selective FGFR inhibitors;
- Have received any other investigational drug treatment or participated in another interventional clinical trial within 28 days before the first dose of the investigational drug, or have received anti-tumor drug treatment within 28 days before the first dose of the investigational drug (including Chinese herbal medicine with anti-tumor indications);
- Have not recovered (i.e., reaching ≤ grade 1 or the baseline status, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment;
- With known symptomatic central nervous system metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases are eligible if the disease is stable (no imaging evidence of progression in at least 4 weeks prior to the first dose of study treatment), there is no evidence of new or enlarging brain metastases on repeated imaging, and corticosteroids are not required in at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis should be excluded regardless of their clinically stability;
- Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation;
Subjects with abnormal laboratory parameters listed below:
- Serum phosphate > ULN;
- Serum calcium exceeds the normal range, or the calcium concentration corrected for serum albumin exceeds the normal range when serum albumin exceeds the normal range;
- Potassium level < lower limit of normal (LLN); potassium levels can be corrected by supplements at screening.
- With known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results;
- Presence of severe infection in the active phase or with poor clinical control;
- Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage;
- Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA > 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who with relevant parameters lower than the above criteria after nucleotide antiviral treatment can be enrolled;
- With clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (subjects with pacemakers or with atrial fibrillation but well controlled heart rate are allowed);
- With ECG changes or medical history considered clinically significant by the investigator; QTcF interval > 480 ms at screening; for subjects with intraventricular conduction block (QRS interval > 120 ms), JTc interval can be used instead of QTc interval (in such cases, JTc must be ≤ 340 ms);
- With uncontrolled hypertension (systolic pressure > 160 mmHg or diastolic pressure > 100 mmHg) after the optimal medical treatment, or a history of hypertensive crisis or hypertensive encephalopathy;
- With hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis with Child-Pugh grade B or C.
- Have received a major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or will receive a major surgery during the study treatment period;
- Not fully recovered from toxicity and/or complications of a major surgery before the commencement of treatment;
- Pregnant or lactating women, or subjects expected to conceive or give birth during the study period from the screening visit to the completion of the safety follow-up visit (90 days after the last dose for male subjects);
- Have received radiotherapy within 4 weeks before the first dose of the investigational drug. The subjects must be completely recovered from radiotherapy-related toxicity, with no need for corticosteroid treatment, and radiation pneumonitis must be excluded. For palliative radiotherapy for non-CNS diseases, a 2-week washout period is allowed;
- Have a history of disorders of calcium and phosphorus metabolism or systemic electrolyte metabolism imbalance with ectopic calcification of soft tissues (excluding calcification of soft tissues such as skin, kidneys, tendon, or blood vessels without systemic electrolyte metabolism imbalance caused by injury, disease, and old age);
- Clinically significant corneal or retinal diseases confirmed by ophthalmological examination;
- Have used any potent CYP3A4 inhibitor (see Appendix A for details) or inducer within 14 days or 5 half lives (whichever is shorter) before the first dose of the investigational drug. Ketoconazole is allowed for external use;
- With known allergic reactions to pemigatinib or excipients of pemigatinib;
- Unable or unwilling to swallow pemigatinib or are suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion;
- Subjects with a history of vitamin D deficiency who require supraphysiological dose of vitamin D (except dietary vitamin D supplements);
- Other acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that may result in an increased risk associated with study participation or investigational drug administration or interfere with the interpretation of study results, and disqualify patients from the study in the investigator's judgment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: selective FGFR1-3 inhibitor
|
The patients will receive 13.5 mg (1 pill/time) of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen, with 21 days as a cycle.
They should take pemigatinib at regular times of the day to avoid the effects of inconsistent timing on plasma concentrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate (ORR)
Time Frame: an expected average of 2 years
|
ORR is defined as the proportion of subjects with complete response (CR) + those with partial response (PR) according to the RECIST1.1 criteria.
|
an expected average of 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI375Y010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric and Colorectal Cancer
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Charite University, Berlin, GermanyCompletedGastric Cancer | Colorectal Cancer | Esophageal CancerGermany
-
Emory UniversityIpsen; Taiho Oncology, Inc.RecruitingGastric Adenocarcinoma | Unresectable Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Colorectal Adenocarcinoma | Stage IV Gastric Cancer | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Stage... and other conditionsUnited States
-
Inspirna, Inc.RecruitingGastrointestinal Neoplasms | Colorectal Neoplasms | Gastric Cancer | Colorectal Cancer | Colorectal Cancer Metastatic | Gastrointestinal Cancer | Colorectal Carcinoma | CRC | KRAS Mutation-Related Tumors | Gastric NeoplasmUnited States
-
Thomas Jefferson UniversitySuspendedMalignant Solid Neoplasm | Gastric Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Colorectal Adenocarcinoma | Small Intestinal Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC... and other conditionsUnited States
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal Cancer, Gastric CancerAustria
-
Western Regional Medical CenterTerminatedBreast Cancer | Gastric Cancer | Colorectal Cancer | Esophageal Cancer | Advanced CancerUnited States
-
Tarus Therapeutics, Inc.Not yet recruitingHepatocellular Carcinoma | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer
-
AstraZenecaDaiichi Sankyo Co., Ltd.Active, not recruitingPart 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer | Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal CancerBelgium, United States, Poland, India, Taiwan, Thailand, Korea, Republic of, Czechia, Russian Federation, United Kingdom, Spain, Australia, Canada, Italy, Netherlands
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedMetastatic Pancreatic Adenocarcinoma | Stage IV Pancreatic Cancer AJCC v6 and v7 | Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Cholangiocarcinoma | Metastatic... and other conditionsUnited States
Clinical Trials on pemigatinib
-
Sun Yat-sen UniversityNot yet recruitingLocally Advanced Unresectable Gastric CancerChina
-
Innovent Biologics (Suzhou) Co. Ltd.Active, not recruiting
-
Innovent Biologics (Suzhou) Co. Ltd.Completed
-
The First Affiliated Hospital of Soochow UniversityRecruitingNon-Small Cell Lung CancerChina
-
The First Affiliated Hospital of Xiamen UniversityRecruiting
-
Institut für Klinische Krebsforschung IKF GmbH...Incyte Biosciences International SàrlRecruitingIntrahepatic Cholangiocarcinoma | FGFR2 Gene Mutation | FGFR2 Gene Translocation | FGFR2 Gene RearrangementGermany
-
The Fourth Affiliated Hospital of Zhejiang University...Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruitingAdvanced Non Small Cell Lung CancerChina
-
Incyte CorporationTerminatedAdvanced or Metastatic Solid Tumors | FGFR Mutations | FGFR TranslocationsUnited States
-
Incyte CorporationH. Lee Moffitt Cancer Center and Research InstituteNo longer available
-
Tianjin Medical University Second HospitalRecruitingSolid Tumor | FGF Receptor Gene Mutation | FGF Amplification | FGF Receptor Gene Family Rearrangement | FGF Receptor Gene TranslocationChina