Evaluation of the Safety and Efficacy of AL3818 in Subjects with Recurrent or Metastatic Ovarian, Fallopian, and Primary Peritoneal Carcinoma
- Conditions
- Recurrent or metastatic platinum refractory, resistant ovarian, fallopian, primary peritoneal cancerOvarian cancer, Fallopian cancer, Primary peritoneal cancer, FGFr, VEGFR
- Registration Number
- JPRN-jRCT2031230010
- Lead Sponsor
- Kitano Tina
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 3
1. Female = > 18 years of age
2. Histologically proven diagnosis of:
Phase III/Part 3:
(1) Platinum-resistant (progression within 6 months after last platinum-based chemotherapy) ovarian, fallopian, or primary peritoneal cancer that meets one of the following criteria:
i. Subject has received at least two prior lines of systemic therapy including a bevacizumab-containing regimen as standard of care
ii. Subject has received at least two prior lines of systemic therapy, has not received a prior bevacizumab-containing regimen and is not eligible or not accessible for a bevacizumab containing regimen based on Investigators assessment
(2) Platinum-refractory (progression during first-line platinum-based chemotherapy)
ovarian, fallopian, or primary peritoneal cancer after at least one prior line of systemic therapy
(3) For groups 1-2 above: Subjects with positive deleterious or suspected deleterious, germline or somatic BRCA mutated status must have received a PARP inhibitor as a prior line of therapy (except a PARP inhibitor is not accessible or not appropriated). Histologic cell types eligible are all cell types of ovarian, fallopian tube, or primary peritoneal cancer.
3. Have measurable disease defined by RECIST 1.1 confirmed by CT or MRI scan within 28 days of enrollment.
4. Life expectancy of = > 3 months at the time of enrollment.
5. Able to take orally administered study medication.
6. Have adequate baseline function and performance status within 28 days of enrollment:
a. Bone marrow function: absolute neutrophil count (ANC) = > 1,500/mm3, platelets = >100,000/mm3
b. Renal function: creatinine = < 1.5 x institutional upper limit normal (ULN) or if creatinine is >1.5 x ULN, creatinine clearance must be > 50 mL/min.
c. Hepatic function: bilirubin = < 1.5 x ULN or = < 3.0 x ULN for subjects with Gilbert Syndrome: AST and ALT = < 3.0 x ULN.
d. Coagulation profile: international normalized ratio (INR) is = < 1.5 and an aPTT or PTT <1.2 x ULN.
e. ECOG performance = < 2
7. Women of child-bearing potential must agree to use contraceptive measures starting 1 week before C1D1 until 6 months after the last dose of study treatment and have a negative serum pregnancy test within 28 days of enrollment.
8. Provide written informed consent and authorization permitting release of Protected Health Information.
9. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
1.Serious, non-healing wound, ulcer or bone fracture.
2.Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to C1D1 (a major surgical procedure is defined as requiring general anesthesia).
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4.Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
5.History or evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor; seizures not controlled with standard medical therapy; and history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of enrollment.
a.Subjects with metastatic CNS tumors may participate in this study if the subject is > 28 days from therapy completion (including radiation and/or surgery), is clinically stable at the time of study enrollment, and is not receiving corticosteroid therapy.
6.Proteinuria on urinalysis within 28 days of enrollment. Subjects discovered to have a urine protein of 1+ on dipstick or = > 30 mg/dl at baseline should undergo a 24-hour urine collection and demonstrate < 1000 mg protein per 24 hours or spot urine protein (mg/dL) to creatinine (mg/dL) ratio must be <1.0 to allow participation in the study.
7.Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease.
8.Women who are pregnant or lactating women, or women possibly pregnant based on the assessment by a physician.
Lactating women can become eligible for this study if they stop breast-feeding, however, they cannot restart the breast-feeding on/after the completion of the study treatment.
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10.Clinically significant, uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
11.Hemoptysis within 3 months prior to enrollment.
12.Acute or chronic liver disease, active hepatitis A or B with known cirrhosis or liver dysfunction.
(In Japan, all subjects are tested for HBV and HCV. For HBV, subjects who are HBsAg (antigen) positive or anti-HBc antibody positive are excluded. In addition, subjects who are HBsAb-positive and simultaneously have HBV DNA > 20 IU/mL or > 1.3 Log IU/mL are also excluded. Subjects who have not been vaccinated, are HBsAb-positive and have a negative HBV DNA result can be included in the study. For HCV, subjects positive for serum HCV antibody and HCV RNA are excluded, but subjects negative for serum HCV antibody and HCV RNA can be included. Even after enrollment, periodic testing will be conducted in accordance with the Guidelines for the Control of Hepatitis B Caused by Immunosuppression and Chemotherapy.)
13.Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.
14.Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life- threatening medical condition that required it.
15.Known history of human immunodeficiency virus infection (HIV).
16.Active bacterial infections requiring systemic antibiotics (excluding uncompli
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method