Gastrointestinal CancerPhase 2NCT05559775
A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastrointestinal Cancer (Excluding Biliary Tract Cancer) Patients With FGFR Alterations Who Have Failed Standard Therapy
A Phase 2 study testing Pemigatinib Pill in people with Gastrointestinal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is a prospective single-arm phase II clinical study. Advanced Gastrointestinal cancer (excluding Biliary Tract Cancer) patients with FGFR 1-3 alterations who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Pemigatinib Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 10 Aug 2025
- Phase
- Phase 2
- 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
- Subjects must sign a written ICF prior to the implementation of any procedures related to the study;
- Aged ≥ 18 years old;
- With histologically or cytologically confirmed advanced metastatic gastrointestinal cancer (excluding biliary tract cancer);
- 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;
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- 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) ≥ 1.5×109/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).
Who cannot join
- Diagnosed with malignant tumors other than gastrointestinal 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, Doctor, 13858195803, hzyingjieer@163.com
About this study
This study is a prospective single-arm phase II clinical study. Advanced Gastrointestinal cancer (excluding Biliary Tract Cancer) patients with FGFR 1-3 alterations who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen. They will be dosed until disease progression or intolerable toxicity. During treatment, clinical tumor imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and then every 12 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Pemigatinib Pill
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemigatinib PillDrug
Also called Pemazyre
13.5mg, po, 2 weeks on/1 week off, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Selective FGFR1-3 inhibitor Receives: Drug: Pemigatinib Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR is defined as the proportion of subjects with complete response (CR) + those with partial response (PR) according to the RECIST1.1 criteria
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start10 Aug 2022
- Primary completion10 Aug 2024 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jieer, Zhejiang Cancer Hospital
- Investigators
- Jieer Ying, Doctor, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559775
- Sponsor's protocol ID
- CIBI375Y009
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastrointestinal Cancer (Excluding Biliary Tract Cancer) Patients With FGFR Alterations Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT05559775
- Acronym / sponsor ID
- CIBI375Y009
- Conditions
- Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 29 Sep 2022 (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 study is a prospective single-arm phase II clinical study. Advanced Gastrointestinal cancer (excluding Biliary Tract Cancer) patients with FGFR 1-3 alterations who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen. They will be dosed until disease progression or intolerable toxicity. During treatment, clinical tumor imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and then every 12 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemigatinib | Experimental | Drug: Pemigatinib PillSelective FGFR1-3 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must sign a written ICF prior to the implementation of any procedures related to the study;
- Aged ≥ 18 years old;
- With histologically or cytologically confirmed advanced metastatic gastrointestinal cancer (excluding biliary tract cancer);
- 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.;
Key exclusion criteria (29 listed)
- Diagnosed with malignant tumors other than gastrointestinal 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;
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 |
|---|---|---|
| Pemigatinib PillAlso: Pemazyre13.5mg, po, 2 weeks on/1 week off, Q3W | Drug | Pemigatinib |
Primary outcome
ORR
Time frame: about 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jieer Ying, Doctor principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib Pill in people with Gastrointestinal Cancer, run by Zhejiang Cancer Hospital 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 11 inclusion and 29 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 29 Sep 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jieer Ying, Doctor (13858195803, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: about 2 years). 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 29 Sep 2022.