MelanomaPhase 1/2MRX34-102NCT02862145
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions
A Phase 1/2 study testing MRX34 and Dexamethasone in people with Melanoma, run by Mirna Therapeutics, Inc..
Trial summary
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Melanoma
- What is being tested?
- MRX34 and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2017
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Advanced or metastatic cutaneous, acral or mucosal melanoma
- Tumor lesions accessible to serial biopsies
- ECOG ≤ 1
- ANC ≥, Plts ≥100,000 /mm3
Who cannot join
- Serious active non-malignant disease
- Central Nervous System metastasis
About this study
Official title: A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
Read the detailed description
MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)
- Conditions
- Melanoma
- Being tested
- MRX34, Dexamethasone
- Keywords
- Biosy accessible melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRX34Drug
Also called miR-Rx34
Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
DexamethasoneDrug
Also called Decadron
Premedication during the week of treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment with MRX34 | Experimental | Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily. Receives: Drug: MRX34; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
Measured: 3 months
Secondary outcomes (1)
Frequency and severity of adverse events associated with MRX34 treatment
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 posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: 5 immune related serious adverse events in Phase 1 study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirna Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Smith, MSN, Study director, Mirna Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862145
- Sponsor's protocol ID
- MRX34-102
- Acronym
- MRX34-102
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
- ClinicalTrials.gov ID
- NCT02862145
- Acronym / sponsor ID
- MRX34-102 / MRX34-102
- Conditions
- Melanoma
- Keywords
- Biosy accessible melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 5 immune related serious adverse events in Phase 1 study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mirna Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Aug 2016 (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 study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
Detailed description
MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with MRX34 | Experimental | Drug: MRX34, Drug: DexamethasoneLiposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- Advanced or metastatic cutaneous, acral or mucosal melanoma
- Tumor lesions accessible to serial biopsies
- ECOG ≤ 1
- ANC ≥, Plts ≥100,000 /mm3
Key exclusion criteria (2 listed)
- Serious active non-malignant disease
- Central Nervous System metastasis
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 |
|---|---|---|
| MRX34Also: miR-Rx34Treatment of melanoma with pharmacodynamics biopsy of tissue and blood | Drug | Treatment with MRX34 |
| DexamethasoneAlso: DecadronPremedication during the week of treatment | Drug | Treatment with MRX34 |
Primary outcome
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
Time frame: 3 months
1 secondary outcome
Frequency and severity of adverse events associated with MRX34 treatment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Susan Smith, MSN study director
Mirna Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRX34 and Dexamethasone in people with Melanoma, run by Mirna Therapeutics, Inc..
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies (time frame: 3 months). 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 Sep 2016.