BridgeMD
Tests treatment safety and results for Solid Tumor, Miscellaneous
Official title Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells
ClinicalTrials.gov ID: NCT06653777
What this study is testing
What is Pemigatinib?
Pemigatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor, miscellaneous.
Also referred to as Pemazyre®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alterations in the fibroblast growth factor receptor (FGFR) gene are involved in the development of cancer. These anomalies are found at very variable frequencies (from less than 1% to around 10%) in cancers of the bile ducts, bladder, uterus, brain, ovary, lung, airways, digestive tract, breast, etc.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed solid tumor
- Patient with locally recurrent unresectable and/or advanced or metastatic disease harbouring a FGFR1,2,3 fusion/rearrangement or mutation
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient for whom there is no appropriate therapeutic alternative and for whom a FGFR inhibitor is indicated by the institution or the regional...
You likely can't join if
- Hematologic malignancies
- Known hypersensitivity or severe reaction to pemigatinib or excipients of pemigatinib
- Patient with a disease and a FGFR alteration covered by a marketed indication for any selective FGFR inhibitor (e.g cholangiocarcinoma with...
- Patient who received prior selective FGFR inhibitor
- Patient who can be included in a recruiting study assessing FGFR inhibitor (including pemigatinib)
- Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed solid tumor
- Patient with locally recurrent unresectable and/or advanced or metastatic disease harbouring a FGFR1,2,3 fusion/rearrangement or mutation
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient for whom there is no appropriate therapeutic alternative and for whom a FGFR inhibitor is indicated by the institution or the regional multidisciplinary consultation meeting and who may derive a benefit...
- Estimated life expectancy \>3 months
- Measurable disease according to response evaluation criteria in solid tumours version 1.1 (RECIST1.1), whatever the disease location. Tumor lesions located in a previously irradiated area, or in an area subjected to...
- Availability of 2 pre-treatment tumor evaluations performed with an interval of at least 4 weeks and no more than 3 months between the examinations (CT or MRI, but same technics for both) and without any cancer...
- Patient with a minimal trend at 0.1 mm/day increase in tumor growth kinetics between pre-treatment and baseline scan, as assessed by the investigator
- Adequate hematologic function: Absolute neutrophil count (ANC) \> 1.5 x 10⁹ /L; platelets \> 75 x 10⁹ /L; haemoglobin \> 9.0 g/dL. Transfusion is allowed with a 2-week washout period before treatment initiation
- Adequate hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2,5 x upper limit of normal (ULN) (≤ 5 x ULN for liver metastasis); total bilirubin \< 1.5 x ULN (\< 2.5 x ULN if...
- Adequate renal function: serum creatinine clearance \> 30 mL/minute based on Cockcroft-Gault formula
- Value of serum phosphate ≤ ULN and value of serum calcium within institutional normal range (or serum albumin-corrected calcium within normal range when serum albumin is outside of the normal range)
- Potassium levels within institutional normal range; supplementation can be used to correct potassium level during the screening.
- Men, and women of childbearing potential must agree to use adequate contraception for the duration of trial participation and for at least one week after the last dose of pemigatinib. Men must also agree to not donate...
- Women of childbearing potential must have a negative serum pregnancy test performed within 14 days before treatment initiation
- Patient is affiliated to a social security system
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from...
What rules you out
- Hematologic malignancies
- Known hypersensitivity or severe reaction to pemigatinib or excipients of pemigatinib
- Patient with a disease and a FGFR alteration covered by a marketed indication for any selective FGFR inhibitor (e.g cholangiocarcinoma with FGFR2-fusion or a FGFR mutation are not eligible, while FGFR1 or 3 fusion are...
- Patient who received prior selective FGFR inhibitor
- Patient who can be included in a recruiting study assessing FGFR inhibitor (including pemigatinib)
- Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination
- Other current malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially...
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues such as skin, kidney tendon, or...
- Significant gastrointestinal disorder(s) that could interfere with absorption, metabolism, or excretion of pemigatinib
- Inability to swallow and retain oral medication
- Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug/treatment administration, New York Heart Association Class III or...
- History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful. A screening QTcF interval \> 480 ms is excluded.
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis); chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed
- Known HIV infection except if undetectable viral load
- Other active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic...
- Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy or other investigational agents within the last 4 weeks (6 weeks for nitrosoureas and mitomycin C). A 1-week washout is...
- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is shorter) before the first dose of study drug
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
- Inability or unlikeliness of the participant to comply with the dose schedule or with the medical evaluations and follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Women who are pregnant or breastfeeding
- History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 international unit (IU)/weekly) to replenish the deficiency.
- Participation in another therapeutic trial within the 30 days prior to inclusion
- Individuals deprived of liberty or placed under protective custody or guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Nice, France
- Paris, France
- Poitiers, France
- Saint-Priest-en-Jarez, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Nice, France; Paris, France; Poitiers, France; Saint-Priest-en-Jarez, France; Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.