Metastatic Renal Cell CancerPhase 1/2NCT02089334
Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer
A Phase 1/2 study testing RX-0201 in people with Metastatic Renal Cell Cancer, run by Rexahn Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Cancer
- What is being tested?
- RX-0201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2014to 17 May 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females ≥ 18 years of age at screening
- Histological or cytological diagnosis of renal cell cancer with a clear-cell component
- Measurable or evaluable disease defined by Response Evaluation Criteria for Solid Tumors (RECIST) ver. 1.1
- Must have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment
- ECOG performance status of 0,1 or 2
- Life expectancy > 3 months
- Provide written informed consent
Who cannot join
- Brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before planned first dose of study drug
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
- Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus)
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before planned first dose of study drug
- Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before planned first dose of study drug
- Taking strong inducers or inhibitors of CYP450s for subjects receiving everolimus
Show all 15Show fewer
- Chronic treatment with corticosteroids or other immunosuppressive agents
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
- Subjects with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
- Major surgery within 2 months before planned first dose of study drug
- Myocardial infarction within the previous 6 months before planned first dose of study drug
- Active infection requiring parenteral antibiotics within 2 weeks before planned first dose of study drug
- Diagnosis of another malignancy within 2 years before planned first dose of study drug, except for superficial skin cancers, or localized, low grade tumors
- Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus
- Sexually active fertile subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 30 days after the last dose of study treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rexahn Site
Albuquerque, New Mexico, 87106
Rexahn Site
Duarte, California, 91010
Rexahn Site
New York, New York, 10065
Rexahn Site
Salt Lake City, Utah, 84112
Rexahn Site
Seattle, Washington, 98101
Rexahn Site
The Bronx, New York, 10467
Rexahn Site
Tucson, Arizona, 85719
About this study
Official title: A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of RX-0201 in Combination With Everolimus to Treat Subjects With Advanced Renal Cell Carcinoma
The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).
Read the detailed description
This multi-center, open-label, randomized, parallel group study of RX-0201 in combination with everolimus, versus everolimus alone to treat subjects with advanced renal cell carcinoma will be conducted in 2 stages. Stage 1 will be an open-label, dose-escalation study of RX-0201 to identify a safe and tolerable dose of RX-0201 up to a target dose of 250 mg/m^2/day when given in combination with everolimus. Stage 2 will be a randomized, open-label, 2-arm study of RX-0201 in combination with everolimus versus everolimus alone. Subjects will receive RX-0201, at the dose identified in Stage 1, in combination with everolimus or everolimus alone, for up to 8 cycles to determine safety and efficacy of the combination.
- Conditions
- Metastatic Renal Cell Cancer
- Being tested
- RX-0201
- Keywords
- renal cell carcinoma, clear cell, renal cancer, metastatic renal cancer, Carcinoma, Renal Cell*/therapy, Humans, Kidney Neoplasms*/therapy
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-0201Drug
Also called Archexin
RX-0201 will be administered in a dose up to 250mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.
In Stage 2, RX-0201 will be administered the dose determined in Stage 1 as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| RX-0201 plus everolimus (Stage 1 & 2) | Experimental | RX-0201 and everolimus will be taken together as described in the Interventions description. Receives: Drug: RX-0201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting Toxicities (DLTs) (Stage 1)
Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities
Measured: after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus
Progression Free Survival (Stage 2)
Median PFS. Progression determined by RECIST v1.1
Measured: 4 months of treatment with RX-0201 and everolimus
Secondary outcomes (3)
Steady State Concentration (Css) of RX-0201 (Stage 1)
Css of RX-0201 at the beginning and end of the 14 day continuous infusion
Measured: predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped
Incidence of Adverse Events, Changes in Clinical Laboratory Tests and Vital Signs Over Time (Stage 1 and Stage 2)
safety of RX-0201 was evaluated through reporting using the grading system in the CTCAE version 4.03 for adverse events and laboratory abnormalities. All statistical methods for safety were descriptive in nature.
Measured: up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up
Best Overall Response as Determined by RECIST v1.1.
Best overall response as determined by RECIST v1.1. Not Evaluable included the subjects who had completed at least one treatment cycle but no overall response evaluation. Not Done included the subjects who dropped out from the study without completing any treatment cycle and overall response evaluation. The best overall response for each subject from all post-baseline time point overall responses was used. The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence, or occurrence of intolerable toxicity, whatever came first.
Measured: Baseline and at weeks 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startAug 2014
- Primary completion26 Apr 2018
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Renal Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02089334
- Sponsor's protocol ID
- RX-0201-P2-A-09
- Status last verified
- Jun 2020
- First submitted
- 13 Mar 2014
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of RX-0201 in Combination With Everolimus to Treat Subjects With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02089334
- Acronym / sponsor ID
- RX-0201-P2-A-09
- Conditions
- Metastatic Renal Cell Cancer
- Keywords
- renal cell carcinoma, clear cell, renal cancer, metastatic renal cancer, Carcinoma, Renal Cell*/therapy, Humans, Kidney Neoplasms*/therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 30 Jun 2020
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 study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).
Detailed description
This multi-center, open-label, randomized, parallel group study of RX-0201 in combination with everolimus, versus everolimus alone to treat subjects with advanced renal cell carcinoma will be conducted in 2 stages. Stage 1 will be an open-label, dose-escalation study of RX-0201 to identify a safe and tolerable dose of RX-0201 up to a target dose of 250 mg/m^2/day when given in combination with everolimus. Stage 2 will be a randomized, open-label, 2-arm study of RX-0201 in combination with everolimus versus everolimus alone. Subjects will receive RX-0201, at the dose identified in Stage 1, in combination with everolimus or everolimus alone, for up to 8 cycles to determine safety and efficacy of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RX-0201 plus everolimus (Stage 1 & 2) | Experimental | Drug: RX-0201RX-0201 and everolimus will be taken together as described in the Interventions description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥ 18 years of age at screening
- Histological or cytological diagnosis of renal cell cancer with a clear-cell component
- Measurable or evaluable disease defined by Response Evaluation Criteria for Solid Tumors (RECIST) ver. 1.1
- Must have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment
- ECOG performance status of 0,1 or 2
Key exclusion criteria (15 listed)
- Brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before planned first dose of study drug
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
- Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus)
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before planned first dose of study drug
- Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before planned first dose of study drug
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-0201Also: ArchexinRX-0201 will be administered in a dose up to 250mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. In Stage 2, RX-0201 will be administered the dose determined in Stage 1 as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles. | Drug | RX-0201 plus everolimus (Stage 1 & 2) |
Primary outcome
Incidence of Dose-limiting Toxicities (DLTs) (Stage 1)
Time frame: after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus
Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities
Progression Free Survival (Stage 2)
Time frame: 4 months of treatment with RX-0201 and everolimus
Median PFS. Progression determined by RECIST v1.1
3 secondary outcomes
Steady State Concentration (Css) of RX-0201 (Stage 1)
Time frame: predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped
Incidence of Adverse Events, Changes in Clinical Laboratory Tests and Vital Signs Over Time (Stage 1 and Stage 2)
Time frame: up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up
Best Overall Response as Determined by RECIST v1.1.
Time frame: Baseline and at weeks 6, 12, 18, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 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-0201 in people with Metastatic Renal Cell Cancer, run by Rexahn Pharmaceuticals, Inc. at 7 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 7 inclusion and 15 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (Stage 1) (time frame: after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus). 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 30 Jun 2020.