Gastrointestinal CancerPhase 2NCT05651672
Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations
A Phase 2 study testing Pemigatinib in people with Gastrointestinal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a prospective single-arm phase II study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Aged 18 or older
- Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic gastrointestinal 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
- Disease progression after prior standard therapy
- No previous use of small molecule multi-target inhibitors targeting the FGFR pathway (including but not limited to anlotinib, lenvatinib, sorafenib, apatinib)
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- ECOG performance status of 0~1
- Expected survival time > 3 months
- Sufficient organ functions
- Negative pregnancy test results of childbearing age women
- Patients at risk of conception (including their partners) need to use contraception
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
- Prior receipt of selective FGFR inhibitors
- Have received any other investigational drug or participated in another interventional clinical trial within 28 days before the first dose, or have received anti-tumor drug treatment within 28 days before the first dose (including Chinese herbal medicine with anti-tumor indications)
- Have not recovered ( ≤ grade 1 or reaching the baseline, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment
- Known symptomatic central nervous system metastasis and/or carcinomatous meningitis.
- Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation
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- Abnormal laboratory parameters listed below:
- Serum phosphate > upper limit of normal (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
- 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
- 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 (patients with pacemakers or with atrial fibrillation but well controlled heart rate are allowed)
- ECG changes or medical history considered clinically significant by the investigator, QTcF interval > 480 ms at screening, JTc interval can be used instead of QTc interval (in such cases, JTc must be ≤ 340 ms) for patients with intraventricular conduction block (QRS interval > 120 ms)
- 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
- 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, 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 study treatment
- Pregnant or lactating women, or patients expected to conceive or give birth during the study period from the screening 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.
- 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
- Prior receipt of any potent CYP3A4 inhibitor or inducer within 14 days or 5 half lives (whichever is shorter) before the first dose. Ketoconazole is allowed for external use
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Wei Lu, +86-22-23340123 ext. 3089, mail4luwei@163.com
Wei Lu, M.D
About this study
Official title: A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations That Failed Standard Therapy
This study is a prospective single-arm phase II study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Pemigatinib
- Keywords
- Gastrointestinal Cancer, Pemigatinib
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called Pemazyre
13.5mg, po, 2 weeks on/1 week off, Q3W
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Pemigatinib Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Defined as proportion of patients who have a best response of complete response (CR) + partial response (PR) according to the RECIST 1.1 criteria
Measured: up to 2 years
Secondary outcomes (5)
Progress Free Survival (PFS)
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Measured: Up to 4 years
Overall Survival (OS)
Defined as the time from enrollment to the death
Measured: Up to 4 years
Duration of Response (DOR)
Defined as the time from the date of CR or PR to PD
Measured: up to 4 years
Disease Control Rate (DCR)
Defined as proportion of patients who have a best response of complete response (CR) + partial response (PR) + stable disease (SD) according to the RECIST1.1 criteria
Measured: Up to 2 years
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start2 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (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 Tianjin Medical University Cancer Institute and 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651672
- Sponsor's protocol ID
- TJ-0046
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations That Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT05651672
- Acronym / sponsor ID
- TJ-0046
- Conditions
- Gastrointestinal Cancer
- Keywords
- Gastrointestinal Cancer, Pemigatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Dec 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 study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: PemigatinibPemigatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 or older
- Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic gastrointestinal 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
- Disease progression after prior standard therapy
Key exclusion criteria (27 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
- Prior receipt of selective FGFR inhibitors
- Have received any other investigational drug or participated in another interventional clinical trial within 28 days before the first dose, or have received anti-tumor drug treatment within 28 days before the first dose (including Chinese herbal medicine with anti-tumor indications)
- Have not recovered ( ≤ grade 1 or reaching the baseline, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment
- Known symptomatic central nervous system metastasis and/or carcinomatous meningitis.
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 |
|---|---|---|
| PemigatinibAlso: Pemazyre13.5mg, po, 2 weeks on/1 week off, Q3W | Drug | experimental group |
Primary outcome
Overall response rate (ORR)
Time frame: up to 2 years
Defined as proportion of patients who have a best response of complete response (CR) + partial response (PR) according to the RECIST 1.1 criteria
5 secondary outcomes
Progress Free Survival (PFS)
Time frame: Up to 4 years
Overall Survival (OS)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: up to 4 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Adverse Events (AEs)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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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.
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 in people with Gastrointestinal Cancer, run by Tianjin Medical University Cancer Institute and 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 27 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: looking for participants now, as of the sponsor's last update on 15 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Lu (+86-22-23340123 ext. 3091, mail4luwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 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 15 Dec 2022.