Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer

Launched by ONCOLIX, INC. · Aug 25, 2015

Keywords

ClinConnect Summary

This study is a first-in-human study designed to establish preliminary human safety, tolerability and pharmacokinetic parameters of Prolanta monotherapy in patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. In addition, biomarkers related to the activity of human prolactin will be examined in tumor samples obtained prior to treatment and at the end of study treatment to determine the pharmacodynamics of the dose levels of Prolanta administered. Three dosing levels will be evaluated, and the dose at which no dose-limiting toxicities are...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects must have recurrent or persistent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. Histologic confirmation of the original primary tumor is required.
• • Subjects shall have had cytoreductive (debulking) surgery.
• • Formalin-fixed, paraffin-embedded tumor tissue blocks must be available for each Subject upon enrollment and provided to Sponsor within 7 days of Day 1.
• • Subjects must have measurable and accessible disease.
• • Subjects must either: (i) have relapsed within 6 months after (or progressed during) their last platinum regimen (this may be their primary/ adjuvant regimen); or (ii) have progressed after 2 or more prior platinum regimens (regardless of duration since most recent platinum regimen); or (iii) can not tolerate platinum therapy due to hypersensitivity or other allergic reactions.
• • In addition to the first platinum-based chemotherapy, Subjects are allowed to have previously received no more than two additional cytotoxic regimens for management of recurrent or persistent disease. "Cytotoxic regimens" include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa.
• • Resolution of any effects of prior therapy (except alopecia) to NCI CTCAE v4.03 grade ≤2 and to baseline laboratory values as defined in inclusion criteria #14.
• • Eastern Cooperative Oncology Group (ECOG) performance status: 0 - 2
• • Life expectancy \>12 weeks
• • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
• • Any prior therapy directed at the malignant tumor, including immunologic agents and chemotherapy, must be discontinued at least four weeks prior to registration (6 weeks for nitrosoureas or mitomycin C).
• • Patients must have normal organ and marrow function as defined.
• • Normal electrocardiogram (ECG) with corrected QT interval (QTc) ≤470 msec.
• Exclusion Criteria:
• • Currently receiving any other investigational agents or having participated in an investigational therapy trial within 30 days.
• • Planned pregnancy, currently pregnant or breastfeeding.
• • Females of childbearing potential who are not using a medically accepted means of contraception (e.g., intrauterine device, oral contraceptive, implant, Depo-Provera®, or barrier devices with spermicide) when engaging in sexual intercourse.
• • History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or history of cerebrovascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months of registration on this study.
• • Serious pre-existing medical conditions such as severe heart disease or uncontrolled: infections, hypertension, hypercalcemia, diabetes, or psychogenic disorders.
• • Have any other concurrent malignancies, except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin. (Subjects who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥ 5 years and patient is deemed to be at low risk for recurrence.)
• • Any other significant medical condition that, in the opinion of the Investigator, would significantly decrease study compliance, jeopardizes the safety of the patient, or affects the validity of the trial results.