NeoplasmsPhase 1NCT01555242
A Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas
A Phase 1 study testing Aneustat (OMN54) in people with Neoplasms, run by Omnitura Therapeutics, Inc. at 1 site in Canada.
Trial summary
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Aneustat (OMN54)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Jan 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological evidence of malignancy
- Male or female, 18 years or older
- Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
- Able to swallow the oral capsule form of the drug
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- Haematology within 7 days of Day 1 (initial dose):
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- Hemoglobin (Hb) > 9.0 g/dL
- Platelets ≥ 100,000 cells/mm3 (or, ≥100 x 10/L)
- Absolute neutrophil count (ANC) > 1.5 cells x109/L (or, > 1500 cells/mm3)
- Chemistry within 7 days of Day 1 (initial dose):
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN if no liver metastases, AST(SGOT)/ALT(SGPT) < 5 x ULN if liver metastases
- Bilirubin < 1.5 x ULN unless Gilbert's Syndrome
- Serum creatinine ≤ 1.25 ULN
- Coagulation within 7 days of Day 1 (initial dose):
- INR ≤ 1.5
- ECOG Performance Status between 0 - 2 and estimated life expectancy of > 3 months.
- Having the initiative and means to be compliant with the protocol (as judged by the Principal Investigator) and is within a feasible geographical proximity of the study center to make the required study visits.
- Written informed consent obtained prior to any study screening procedures
- Females of childbearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus) must have a negative urine pregnancy test (UPT) within 7 days of Day 1 (initial dose)
- Females of childbearing potential must agree to use an effective method of contraception (i.e., sexual abstinence, condoms, intrauterine device, diaphragm) from Screening period and throughout study participation.
Who cannot join
- Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
- Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
- Major surgery within 30 days prior to first dose (Day 1).
- Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY Heart Association Class III or IV, see Appendix 3), unstable angina pectoris, unstable cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
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- Screening (within approximately 28 days of registration) 12-lead electrocardiogram (ECG) that is abnormal and clinically significant
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
- Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial dosing)
- Intolerance or aversion to porcine ingredients that are used for the OMN54 oral capsules in the investigational medicine, OMN54 (Aneustat™).
- Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54), or other similar plants; or to plants belonging to Labiatae or Lamiaceae families, soy, or Aneustat™ (OMN54) excipients
- Use of Sophora subprostrata root (SSR) or herba serissae within 14 days prior to Day 1.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency-Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
Read the detailed description
Patients who complete a 28-day cycle, may be eligible to continue receiving Aneustat™ (OMN54) in 4-week increments for up to 6 cycles (inclusive of cycle 1) if further treatment is judged to be of possible benefit; if patient has not experienced unacceptable toxicity; and no study withdrawal criteria has been met.
- Conditions
- Neoplasms
- Being tested
- Aneustat (OMN54)
- Keywords
- Advanced Cancer, Lymphoma, Refractory
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneustat (OMN54)Drug
100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Aneustat (OMN54) | Experimental | Not described Receives: Drug: Aneustat (OMN54) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
The maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).
Dose Limiting Toxicity (DLT) of two dosing regimens (once daily and twice daily)
Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Plasma blood concentrations of chemical markers
These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
Secondary outcomes (2)
Tumor Response
Tumor response as per RECIST criteria version 1.1, and tumor markers in plasma, as applicable
Measurement of pathway biomarkers in plasma
Plasma concentrations of cancer-related proteins to help characterize Aneustat (OMN54) activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omnitura Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555242
- Sponsor's protocol ID
- OMN54-101
- Status last verified
- Apr 2015
- First submitted
- 13 Mar 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas
- ClinicalTrials.gov ID
- NCT01555242
- Acronym / sponsor ID
- OMN54-101
- Conditions
- Neoplasms
- Keywords
- Advanced Cancer, Lymphoma, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Omnitura Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Mar 2012 (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 is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
Detailed description
Patients who complete a 28-day cycle, may be eligible to continue receiving Aneustat™ (OMN54) in 4-week increments for up to 6 cycles (inclusive of cycle 1) if further treatment is judged to be of possible benefit; if patient has not experienced unacceptable toxicity; and no study withdrawal criteria has been met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneustat (OMN54) | Experimental | Drug: Aneustat (OMN54) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histological or cytological evidence of malignancy
- Male or female, 18 years or older
- Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
- Able to swallow the oral capsule form of the drug
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
Key exclusion criteria (12 listed)
- Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
- Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
- Major surgery within 30 days prior to first dose (Day 1).
- Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
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 |
|---|---|---|
| Aneustat (OMN54)100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID | Drug | Aneustat (OMN54) |
Primary outcome
Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
The maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).
Dose Limiting Toxicity (DLT) of two dosing regimens (once daily and twice daily)
Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Plasma blood concentrations of chemical markers
These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
2 secondary outcomes
Tumor Response
Measurement of pathway biomarkers in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneustat (OMN54) in people with Neoplasms, run by Omnitura Therapeutics, Inc. at 1 site in Canada.
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 20 inclusion and 12 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: finished, as of the sponsor's last update on 8 Apr 2015. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily). The study lists 3 primary outcomes in all. 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 8 Apr 2015.