Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cā¦ (NCT02540356) | Clinical Trial Compass
TerminatedPhase 1/2
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
United States2 participantsStarted 2015-11-02
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Provision of a signed informed consent
ā. Female participants of non-childbearing potential, ā„18 years of age
ā. Anticipated life expectancy \>3 months at the time of screening
ā. Metastatic ovarian epithelial cancer that are platinum-resistant, and has no better option available in the investigator's opinion
ā. Recurrent symptomatic malignant ascites having required at least 2 paracenteses within a 45-day interval prior to baseline paracentesis
ā. Participants who have an indwelling draining IP catheter (to be drained only under medical supervision)
ā. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
ā. Adequate hematological function, defined as:
Exclusion criteria
ā. Known central nervous system metastasis that is unstable within the last 2 months
What they're measuring
1
The Occurrence of Dose-limiting Toxicity (DLT)
Timeframe: 4 weeks
2
The Ratio of Puncture Free Survival (PuFS) Over Puncture-free Interval at Baseline
. 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
ā. Residual AEs \>Grade 2 from previous treatment
ā. Myocardial infarction within 6 months prior to C1D1 treatment, 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 participant is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long QT syndrome)
ā. Uncontrolled hypertension defined as systolic blood pressure ā„160 mmHg and/or diastolic blood pressure ā„100 mmHg confirmed upon repeated measures
ā. Left ventricular ejection fraction \<50% as determined by echocardiogram (ECHO) performed at screening or within 30 days prior to C1D1
ā. QT/QTc interval \>480 msec, before C1D1 treatment administration, as determined by screening electrocardiogram (ECG)
ā. Received anti-tumor therapy (chemotherapy, investigational product, radiotherapy, retinoid therapy, or hormonal therapy) within 2 weeks (less than 14 days) prior to C1D1 with no residual toxicity \>Grade 1; antibody therapy, molecular targeted therapy within 5 half-lives prior to C1D1