An early development study of BAX69 in patients with ovarian cancer with the accumulation of fluid in the abdomen.

Phase 1

Conditions: Refractory Ovarian Cancer withMalignant Ascites
MedDRA version: 18.1Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003492-29-HU

Lead Sponsor: Baxalta Innovations GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1. Provision of a signed informed consent
2. Female subjects of non-childbearing potential, 18 years of age and older at the
time of screening
3. Anticipated life expectancy >3 months at the time of screening
4. Metastatic ovarian epithelial cancer that is platinum resistant, and has no better
option available in the investigator’s opinion
5. Recurrent symptomatic malignant ascites having required 2 paracentesis within a 30-day interval prior to screening
6. ECOG PS of 0 to 2
7. Adequate hematological function, defined as:
Platelet count =100,000/µL
Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
<1.5 times the upper limit of normal (ULN)
Absolute neutrophil count =1,000/µL
Hemoglobin =9 g/dL, without the need for transfusion in the 2 weeks prior to
screening
8. Adequate renal function, defined as serum creatinine =2.0 times ULN and
creatinine clearance >50 mL/min or eGFR >50 mL/min/1.73 m2
9. Adequate liver function, defined as:
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
=2.5 times ULN for subjects without liver metastases, or =5 times ULN in the
presence of liver metastases
Bilirubin =2.0 times ULN, unless subject has known Gilbert’s syndrome
10. Adequate venous access
11. Subject is willing and able to comply with the requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1. Known central nervous system metastases
2. Prior malignancy within the past 3 years, with the exception of curatively treated
basal or squamous cell carcinoma of the skin, ductal carcinoma in situ of breast,
in situ cervical carcinoma, and superficial bladder cancer
3. Subjects who have an indwelling draining intraperitoneal catheter
4. Residual AEs >Grade 2 from previous treatment
5. Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of
congestive heart failure (New York Heart Association Class III or IV), unstable
angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at
risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or
long QT syndrome)
6. Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or
diastolic blood pressure =100 mmHg confirmed upon repeated measures
7. Left ventricular ejection fraction <40% as determined by echocardiogram
(ECHO) performed at screening or within 90 days prior to C1D1
8. QT/QTc interval >450 msec, before C1D1 treatment administration, as
determined by screening ECG
9. Received anti-tumor therapy (chemotherapy, radiotherapy, retinoid therapy, or
hormonal therapy) within 4 weeks (less than 28 days) prior to C1D1; antibody
therapy, molecular targeted therapy within 5 half-lives prior to C1D1.
10. Major surgery within 4 weeks (less than 28 days) prior to C1D1
11. Active joint inflammation or other immune disorder involving joints
(osteoarthritis is not exclusionary)
12. Active infection involving IV antibiotics within 2 weeks prior to C1D1
13. Positive serology test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
active tuberculosis
14. Positive serology test for human immunodeficiency virus (HIV) type 1 and 2, or
known history of other immunodeficiency disease
15. Albumin <3g/dL or total protein <6g/dL (it is not exclusionary if the patient receives albumin prophylactically)
16. Subject has received a live vaccine within 2 weeks (less than 14 days) prior to
C1D1
17. Known hypersensitivity to any component of recombinant protein production by
Chinese Hamster Ovary cells.
18. Exposure to an investigational product or investigational device in another
clinical study within 4 weeks (less than 28 days) prior to screening, or is
scheduled to participate in another clinical study involving an investigational
product or device during the course of this study
19. Any disorder or disease, or clinically significant abnormality on laboratory or
other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the
investigator may impede the subject’s participation in the study, pose increased
risk to the subject, and/or confound the results of the study
20. Subject is a family member or employee of the investigator.