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New treatment option for Advanced Solid Tumor
Official title Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
ClinicalTrials.gov ID: NCT06302621
What this study is testing
What is Afatinib?
Afatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Also referred to as Gilotrif™.
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
- This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors. The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
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
- All Patients
- Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or...
- FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined...
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- At least 18 years of age.
You likely can't join if
- Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib
- For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis...
- Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib...
- Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful adverse events (AEs) can...
- Major surgery within 4 weeks prior to planned start of pemigatinib and afatinib (tumor biopsy, biliary stent or catheter placement, and feeding tube...
- Received prior palliative non-CNS radiation within 2 weeks or extended-field radiation administered within 4 weeks of first dose of study drug...
See the full eligibility criteria
Who can join
- All Patients
- Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the...
- FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined by testing routinely performed at a Clinical Laboratory Improvement...
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- At least 18 years of age.
- Ability to swallow tablets.
- Life expectancy \>/=3 months
- Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
- Patients with cholangiocarcinoma must have adequate biliary drainage (per investigator's discretion), with no evidence of ongoing infection.
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
- Measurable or non-measurable disease as determined by RECIST 1.1.
- Adequate organ function defined as:
- ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases
- Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN
- Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml/min
- Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
- Absolute Neutrophil Count ≥ 1.5 x 109/L
- Platelets ≥ 75 x 109/L
- INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy
- NOTE: Transfusions to increase a patient's hemoglobin level or initiation of erythropoietin or G-CSF therapy to meet enrollment criteria are not allowed in the 14 days preceding the first dose of study drug. If a...
- Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma
- No prior treatment with a selective FGFR inhibitor treatment
- FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion on tumor profiling in tumor tissue as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified...
- An archived tumor tissue sample is available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh...
- Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma
- Prior FGFR inhibitor treatment at any time prior to treatment start is required
- FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR...
- An archived tumor tissue sample after progression on or intolerance of prior FGFR inhibitor available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are...
What rules you out
- Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib
- For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs; activating mutations in the FGFR2...
- Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib and afatinib.
- Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful adverse events (AEs) can be made with input from the principal investigator.
- Major surgery within 4 weeks prior to planned start of pemigatinib and afatinib (tumor biopsy, biliary stent or catheter placement, and feeding tube placement are not considered major surgical procedures).
- Received prior palliative non-CNS radiation within 2 weeks or extended-field radiation administered within 4 weeks of first dose of study drug. people must have recovered from all radiation-related toxicities, not...
- Known pre-existing interstitial lung disease
- Current hypovitaminosis D requiring supraphysiologic (eg 50,000 IU/weekly) to replenish the deficiency. Vitamin D supplements are allowed.
- History and/or current evidence of clinically significant ectopic mineralization/calcification or non-tumor related alteration of calcium-phosphorus homeostasis.
- History and/or current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmological examination
- Child-Pugh B and C cirrhosis
- Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator. This includes significant or recent gastrointestinal disorders with diarrhea as a major symptom
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- Patients with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone...
- Have history of hepatic encephalopathy of any grade
- Patients with ascites requiring serial paracenteses
- Active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate provided that they are stable for ≥ 2 months. Patients with suspected or confirmed...
- Clinically significant, active cardiovascular disease such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia...
- Fridericia's corrected QT interval (QTcF) \> 480 ms on ECG conducted during Screening, or history of torsades de pointes or personal or family history of prolonged QT syndrome.Correction of suspected drug-induced QTcF...
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and the...
- Active hepatitis B virus (HBV) \-- Note: Controlled (treated) hepatitis will be allowed if they meet the following criteria: antiviral therapy for HBV must be given for at least 1 month prior to first dose of study...
- Known human immunodeficiency virus (HIV) and on anti-retroviral therapy for HIV(excluded due to potential drug-drug interactions between anti-retroviral medications and study treatment but HIV itself is not an...
- Known or suspected active drug or alcohol use
- Concomitant treatment with known strong p-gp inhibitor.
- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. \-- Note: Moderate CYP3A4 inhibitors are not...
- Pregnancy during the study or within 30 days of the last dose of study intervention. Also excluded are any persons of childbearing potential, including men who are able to father a child, who are unwilling to use a...
- Unable to swallow pills
- Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Boston, Massachusetts, United States. 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.