Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer

NCT02534922 | Unknown Phase 1 DMC

• 1 other identifier: ONC-OC-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a Phase I open-label safety study of Prolanta™, a recombinant analog of the human prolactin protein with a single amino acid substitution to create an antagonist of the prolactin receptor. The Sponsor believes that blocking the prolactin receptor in patients with ovarian and other cancers will be effective as a monotherapy or in combination with other chemotherapies. This Phase I study will be conducted in Subjects with recurrent or persistent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with Treatment Related Adverse Events by CTCAE v4.03

  The Common Toxicity Criteria for Adverse Effects (CTCAE), version 4.03, graded toxicity scale will be utilized to assess local and systemic toxicity. Dose Limiting Toxicity is defined as any grade 3 or higher toxicity or any grade 2 hypersensitivity reaction or neurologic toxicity.

  90 days

Study Arms (1)

Daily dosing

EXPERIMENTAL

Daily subcutaneous dosing of Prolanta, a human prolactin receptor antagonist

Biological: Prolanta, a human prolactin receptor antagonist

Interventions

Prolanta, a human prolactin receptor antagonist BIOLOGICAL

Daily subcutaneous dosing

Daily dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncolix, Inc.: lead

Study Sites (1)

ITOR/GHS

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Michael T Redman

  Oncolix, Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael T Redman

CONTACT

2814023167; MRedman@OncolixBio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 28, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

US (1)