Solid TumorPhase 1/2NCT02003092
RX-5902 Treatment of Subjects With Triple Negative Breast Cancer
A Phase 1/2 study testing RX-5902 in people with Solid Tumor and Triple Negative Breast Cancer, run by Rexahn Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Triple Negative Breast Cancer
- What is being tested?
- RX-5902
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2013to Nov 2019
- Phase
- Phase 1/2
- 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
- Male and female who are 18 yrs or older
- Histologically confirmed triple negative breast cancer that are refractory, intolerant, or ineligible to receive approved standard therapies
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of at least 3 months
- Able to swallow capsules
- Provide written informed consent
Who cannot join
- Primary brain tumor or active brain metastasis
- Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
- Any other cancer treatments within 2 weeks of planned study treatment
- History of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study results
- History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
- Uncontrolled diabetes
Show all 16Show fewer
- History of long QT syndrome or clinically significant cardiac arrhythmias (except stable atrial fibrillation)
- Myocardial infarction within 6 months of study dose
- Active infection requiring IV antibiotics within 2 weeks of study dose
- History of Hepatitis B, C, or HIV
- Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
- Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
- Receiving other investigational agents or not yet completed 30 days since completion of an investigational study
- Pregnant, planning a pregnancy, or breast feeding
- Male or female not willing to use adequate contraceptive precautions during the study period. Females must either be surgically sterile, post-menopausal for 12 months, or use a contraceptive approved by sponsor.
- Unwilling or unable to provide written informed consent, comply with study requirements, or be available for follow-up assessments
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rexahn site
Arlington, Virginia, 22031
Rexahn Site
Aurora, Colorado, 80045
Rexahn site
Chicago, Illinois, 60637
Rexahn Site
Detroit, Michigan, 48202
Rexahn Site
Greenville, South Carolina, 29605
Rexahn Site
Hackensack, New Jersey, 07601
Rexahn Site
New York, New York, 10065
Rexahn site
Tucson, Arizona, 85724
About this study
Official title: A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.
Read the detailed description
In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.
- Conditions
- Solid Tumor, Triple Negative Breast Cancer
- Being tested
- RX-5902
- Keywords
- Metastatic, Rexahn, Phase 1, Triple Negative Breast Cancer, Phase 2, Relapsed
- Medical subject headings
- Triple Negative Breast Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-5902Drug
Also called Supinoxin™
escalating doses (mg)
| Study group | Role | What they receive |
|---|---|---|
| RX-5902 | Experimental | RX-5902 will be taken daily for 4 weeks in each 4 week cycle. Subjects will be fasting for 8 hours before and food may be ingested approximately 3 hours after the dose has been administered. Receives: Drug: RX-5902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs) (Phase 1)
Measured: after 4 weeks of treatment with RX-5902
Progression free survival rate and/or overall clinical response rate (Phase 2)
Measured: 16 weeks of treatment with RX-5902
Secondary outcomes (5)
Area under the plasma concentration versus time curve (AUC) of RX-5902
Measured: predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
Changes in tumor size mm
Measured: baseline and 24 weeks
Time to progression (Phase 2)
Measured: Baseline and at 4, 8, 12, 16 and 24 weeks
Duration of response (Phase 2)
Measured: Baseline and at 4, 8, 12, 16 and 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ely Benaim, MD, Study director, Rexahn Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003092
- Sponsor's protocol ID
- RX-5902-P1-01
- Status last verified
- Jan 2020
- First submitted
- 15 Nov 2013
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02003092
- Acronym / sponsor ID
- RX-5902-P1-01
- Conditions
- Solid Tumor, Triple Negative Breast Cancer
- Keywords
- Metastatic, Rexahn, Phase 1, Triple Negative Breast Cancer, Phase 2, Relapsed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 6 Dec 2013 (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.
The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.
Detailed description
In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RX-5902 | Experimental | Drug: RX-5902RX-5902 will be taken daily for 4 weeks in each 4 week cycle. Subjects will be fasting for 8 hours before and food may be ingested approximately 3 hours after the dose has been administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female who are 18 yrs or older
- Histologically confirmed triple negative breast cancer that are refractory, intolerant, or ineligible to receive approved standard therapies
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of at least 3 months
- Able to swallow capsules
Key exclusion criteria (16 listed)
- Primary brain tumor or active brain metastasis
- Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
- Any other cancer treatments within 2 weeks of planned study treatment
- History of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study results
- History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
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 |
|---|---|---|
| RX-5902Also: Supinoxin™escalating doses (mg) | Drug | RX-5902 |
Primary outcome
Incidence of dose limiting toxicities (DLTs) (Phase 1)
Time frame: after 4 weeks of treatment with RX-5902
Progression free survival rate and/or overall clinical response rate (Phase 2)
Time frame: 16 weeks of treatment with RX-5902
5 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of RX-5902
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
Changes in tumor size mm
Time frame: baseline and 24 weeks
Time to progression (Phase 2)
Time frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Duration of response (Phase 2)
Time frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
Ely Benaim, MD study director
Rexahn Pharmaceuticals, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RX-5902 in people with Solid Tumor and Triple Negative Breast Cancer, run by Rexahn Pharmaceuticals, Inc. at 8 sites 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Incidence of dose limiting toxicities (DLTs) (Phase 1) (time frame: after 4 weeks of treatment with RX-5902). The study lists 2 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 6 Jan 2020.