A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
- Conditions
- Bile duct cancerCholangiocarcinoma10019815
- Registration Number
- NL-OMON52434
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Participants are eligible to be included in the study only if all of the
following criteria apply:
1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Male and female participants at least 18 years of age at the time of signing
the ICF; a legally minor participant from Japan needs written parental consent.
3. Histologically or cytologically confirmed cholangiocarcinoma that is
previously untreated and considered unresectable and/or metastatic (Stage IV
per the AJCC Cancer Staging Manual [AJCC 2010]).
4. Radiographically measurable or evaluable disease by CT or MRI per RECIST
v1.1 criteria.
5. ECOG performance status 0 to 1.
6. Documented FGFR2 rearrangement.
Participants are excluded from the study if any of the following criteria apply:
1. Received prior anticancer systemic therapy for unresectable and/or
metastatic disease (not including adjuvant/neoadjuvant treatment completed at
least 6 months prior to enrollment, and participants that have received
treatment for locally advanced disease with trans-arterial chemoembolization or
selective internal radiation therapy, if clear evidence of radiological
progression is observed before enrollment, or enrolled as of Amendment 6 and
the participant received 1 cycle of gemcitabine plus cisplatin [the start of
study drug {Cycle 1 Day 1} must be at least 14 days and <= 4 weeks {28 days}
from the last dose of gemcitabine plus cisplatin]).
2. In participants with liver cirrhosis, Child-Pugh B and C (Note: Ascites
attributed to cholangiocarcinoma rather than liver dysfunction (eg, in the
presence of peritoneal metastases) should not be taken into consideration when
scoring).
3. Toxicities related to prior therapy(ies) must be CTCAE v5.0 <= Grade 1 at the
time of screening.
4. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,
immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or
tumor embolization), other than the therapies being tested in this study.
5. Participant is a candidate for potentially curative surgery.
6. Current evidence of clinically significant corneal (including but not
limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration,
and keratoconjunctivitis) or retinal disorder (including but not limited to
central serous retinopathy, macular/retinal degeneration, diabetic retinopathy,
retinal detachment) as confirmed by ophthalmologic examination.
7. Radiation therapy administered within 4 weeks of enrollment/randomization/
first dose of study treatment. Participants must have recovered from all
radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. Evidence of fibrosis within a radiation field from prior
radiotherapy is permitted with medical monitor approval. A 2-week washout is
permitted for palliative radiation to non-CNS disease.
8. Known CNS metastases or history of uncontrolled seizures. Participants with
treated brain metastases are eligible if there is no evidence of progression
for at least 4 weeks after CNS-directed treatment, as ascertained by clinical
examination and brain imaging (MRI or CT scan) during the screening period, and
they are on stable or decreasing dose of corticosteroids for at least 1 week.
9. Known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of
the skin, or in situ cervical cancer that has undergone potentially curative
therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression Free Survival: defined as the time from date of randomization until<br /><br>date of disease progression (according to RECIST v1.1 and assessed by an ICR)<br /><br>or death, whichever occurs first.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Overall Response rate (complete response(CR) + Partial Response(PR)): defined<br /><br>as the proportion of participants with best overall response of CR or PR per<br /><br>RECIST v1.1 as assessed by an ICR.<br /><br>• Overall Survival: defined as the time from date of randomization until death<br /><br>due to any cause. </p><br>