Platinum resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer MedDRA version: 21.1 Level: LLT Classification code 10003758 Term: Atypical proliferating ovarian tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: Anlotinib Hydrochloride
Product Code: [AL3818 Hydrochloride]
Pharmaceutical Form: Tablet
INN or Proposed INN: Catequentinib, Anlotinib
CAS Number: 1058156-90-3
Current Sponsor code: AL38
Sponsors
ADVENCHEN LABORATORIES, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 for a bevacizumab containing regimen based on Investigator’s 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. Histologic cell types eligible are squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma 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 × ULN. d. Coagulation profile: international normalized ratio (INR) is = 1.5 and an aPTT or PTT =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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). 3. (Intentionally left blank) 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 160 mm Hg or diastolic BP >90 mm Hg pressure. 22. QT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy between the Active Arm (AL3818 in combination with background chemotherapy) and Control Arm (background chemotherapy alone arm) as measured by the primary endpoint of Progression Free Survival (PFS). PFS will be evaluated by a blinded independent radiological review (BICR).;Secondary Objective: To evaluate the efficacy between the Active Arm and Control Arm as measured by the secondary endpoints of objective response rate (ORR), duration of response (DOR), and Overall Survival (OS). ORR will be evaluated by a blinded independent radiological review (BICR).;Primary end point(s): Progression Free Survival (PFS) is defined as the median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs earlier. PFS will be evaluated by a blinded independent radiological review (BICR).;Timepoint(s) of evaluation of this end point: Primary endpoint pf Progression Free Survival (PFS): The length of time during and after the treatment of a disease (cancer) that a patient lives with the disease but it does not get worse. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective Tumor Response Rate (ORR) is defined as the proportion of subjects who achieve Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1. and duration of response. ORR will be evaluated by a blinded independent radiological review (BICR). 2. Duration of Response (DOR) is defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes. 3. Overall Survival (OS) is defined as the time from randomization until death from any cause.;Timepoint(s) of evaluation of this end point: Objective response rate (ORR): the assessment of the tumor burden (TB) after a given treatment in patients with solid tumors and has a long history. Duration of response (DOR): the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. Overall Survival (OS): the time from randomization to death from any cause, is a direct measure of clinical benefit to a patient. | — |
Countries
China, Italy, Spain, United Kingdom, United States
Contacts
Public ContactN.A.
ADVENCHEN LABORATORIES, LLC
Outcome results
None listed