LymphomaPhase 1NCT03119467
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
A Phase 1 study testing RP4010 in people with Lymphoma, run by Rhizen Pharmaceuticals SA at 11 sites in 2 countries.
Trial summary
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- RP4010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 11 May 2017to 19 Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory to or relapsed after at least 1 prior treatment line.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patients must be ≥18 years of age
- Able to give a written informed consent.
Who cannot join
- Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
- Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection
- Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.
- Patients with graft versus-host disease (GVHD)
- Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .
- Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV);
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- Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec;
- Patient with angina not well-controlled by medication;
- Women who are pregnant or lactating.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
University of Alabama
Birmingham, Alabama, 35294-3300
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Australia4 sites
Pindara Private Hospital
Benowa, Queensland, 4217
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes, Queensland, 4120
Epworth HealthCare
Richmond, Victoria, 3121
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official title: A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Read the detailed description
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).
Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).
Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).
- Conditions
- Lymphoma
- Being tested
- RP4010
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP4010Drug
Escalating doses starting at 25 mg
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | RP4010 to be administered Receives: Drug: RP4010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) Determination
To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Measured: 28 days
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax).
To assess the Maximum Plasma Concentration (Cmax).
Measured: 24 hrs
Area under the curve (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Measured: 24 hrs
Anti-tumor activity-Overall response rate (ORR)
To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start11 May 2017
- Primary completion29 Nov 2019
- Study completion19 Dec 2019
Why it stopped: Study has been stopped after reviewing PK and safety results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119467
- Sponsor's protocol ID
- RP4010-1601
- Status last verified
- Dec 2019
- First submitted
- 10 Apr 2017
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
- ClinicalTrials.gov ID
- NCT03119467
- Acronym / sponsor ID
- RP4010-1601
- Conditions
- Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been stopped after reviewing PK and safety results
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Detailed description
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).
Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).
Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: RP4010RP4010 to be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Refractory to or relapsed after at least 1 prior treatment line.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patients must be ≥18 years of age
- Able to give a written informed consent.
Key exclusion criteria (9 listed)
- Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
- Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection
- Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.
- Patients with graft versus-host disease (GVHD)
- Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .
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 |
|---|---|---|
| RP4010Escalating doses starting at 25 mg | Drug | Single arm |
Primary outcome
Maximum Tolerated Dose (MTD) Determination
Time frame: 28 days
To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
3 secondary outcomes
Maximum Plasma Concentration (Cmax).
Time frame: 24 hrs
Area under the curve (AUC)
Time frame: 24 hrs
Anti-tumor activity-Overall response rate (ORR)
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Study has been stopped after reviewing PK and safety results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP4010 in people with Lymphoma, run by Rhizen Pharmaceuticals SA at 11 sites in 2 countries.
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 4 inclusion and 9 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. 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 was stopped early (reason given: Study has been stopped after reviewing PK and safety results). 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?
Maximum Tolerated Dose (MTD) Determination (time frame: 28 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 27 Dec 2019.