Ovarian CancerPhase 1ProlantaOCNCT02534922
Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer
A Phase 1 study testing Prolanta, a human prolactin receptor antagonist in people with Ovarian Cancer and Peritoneal Cancer, run by Oncolix, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Prolanta, a human prolactin receptor antagonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ITOR/GHS
Greenville, South Carolina, 29605
Lisa Johnson, RN, 864-455-3600, ljohnson4@ghs.org
Jill Cantrell, RN, 8644553600, jcantrell@ghs.org
About this study
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
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.
Read the detailed description
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
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Prolanta, a human prolactin receptor antagonist
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolanta, a human prolactin receptor antagonistBiological
Daily subcutaneous dosing
| Study group | Role | What they receive |
|---|---|---|
| Daily dosing | Experimental | Daily subcutaneous dosing of Prolanta, a human prolactin receptor antagonist Receives: Biological: Prolanta, a human prolactin receptor antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncolix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael T Redman, Study director, Oncolix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534922
- Sponsor's protocol ID
- ONC-OC-001
- Acronym
- ProlantaOC
- Status last verified
- Feb 2018
- First submitted
- 24 Aug 2015
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02534922
- Acronym / sponsor ID
- ProlantaOC / ONC-OC-001
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oncolix, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily dosing | Experimental | Biological: Prolanta, a human prolactin receptor antagonistDaily subcutaneous dosing of Prolanta, a human prolactin receptor antagonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolanta, a human prolactin receptor antagonistDaily subcutaneous dosing | Biological | Daily dosing |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Redman study director
Oncolix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prolanta, a human prolactin receptor antagonist in people with Ovarian Cancer and Peritoneal Cancer, run by Oncolix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael T Redman (2814023167, MRedman@OncolixBio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Treatment Related Adverse Events by CTCAE v4.03 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.