Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer (ProlantaOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02534922|
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer||Biological: Prolanta, a human prolactin receptor antagonist||Phase 1|
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 observed will be the recommended Phase II dose.
Because of its antagonist effect and the expected lower toxicity, Sponsor believes that Prolanta may be administered continuously as a monotherapy or in conjunction with the periodic administration of chemotherapy (i.e., a dual therapy). The dosing schedule to be used in this trial is designed to evaluate, in increments, the safety and tolerability of Prolanta over this 90 day cycle. Subjects will be assessed for antibody presence throughout the study, initially on a weekly basis and then bi-weekly. Subjects will be initially dosed for 28 days followed by a safety assessment period, and then continue for an additional 56 days if no toxicities are observed.
The primary objectives of this study are to determine the safety and tolerability of Prolanta in women with recurrent ovarian cancer and to determine the optimal dose of Prolanta to use in Phase II studies. The safety evaluation will be determined by assessing treatment-emergent adverse events, physical examination, ECG, changes in clinical laboratory results including clinical chemistry, hematology and urinalysis, changes in pituitary hormone levels, and vital signs including blood pressure, pulse and respiratory rate. The optimal dose of Prolanta will be determined by evaluating both the safety profile and blood levels of Prolanta. If possible, the effect of the Prolanta dose on tumor biomarkers and tumor burden will also be used to determine the optimally bioactive Phase II dose level.
The secondary objectives of this study are (i) to determine the pharmacokinetic parameters of Prolanta including Cmax, Tmax, half-life and area under the curve (AUC); (ii) to determine the effect of treatment with Prolanta on tumor markers; (iii) to determine clinical efficacy of Prolanta by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open-Label, Dose-Escalation and Pharmacokinetic Study of Subcutaneous Prolanta™ in Subjects With Recurrent or Persistent Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Daily dosing
Daily subcutaneous dosing of Prolanta, a human prolactin receptor antagonist
Biological: Prolanta, a human prolactin receptor antagonist
Daily subcutaneous dosing
- Number of Subjects with Treatment Related Adverse Events by CTCAE v4.03 [ Time Frame: 90 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534922
|Contact: Michael T Redman||2814023167||MRedman@OncolixBio.com|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|Contact: Lisa Johnson, RN 864-455-3600 firstname.lastname@example.org|
|Contact: Jill Cantrell, RN 8644553600 email@example.com|
|Study Director:||Michael T Redman||Oncolix, Inc.|