CholangiocarcinomaPhase 2EPICNCT02452970
RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
A Phase 2 study testing RRx-001 and Gemcitabine and cisplatin in people with Cholangiocarcinoma, run by EpicentRx, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- RRx-001 and Gemcitabine and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2015to 25 May 2016
- Phase
- Phase 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
- Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma
- Must have locally advanced or distant metastatic disease that is not surgically curable
- Failed first-line chemotherapy
- Age ≥ 18 years
- Life expectancy of at least 12 weeks (3 months)
- Performance status 0 or 1
- Adequate liver, kidney, and bone marrow function
Who cannot join
- Symptomatic metastatic brain or meningeal tumors
- Investigational compound within 4 weeks of enrollment
- History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
- Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
- Pregnant or nursing
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Show all 9Show fewer
- Albumin <2.8
- Uncontrolled or clinically relevant ascites
- Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma.
The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred.
The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.
- Conditions
- Cholangiocarcinoma
- Being tested
- RRx-001, Gemcitabine and cisplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001Drug
RRx-001 (10 mg/m2) intravenously twice weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 30 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
Gemcitabine and cisplatinDrug
RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
| Study group | Role | What they receive |
|---|---|---|
| RRx-001 the cisplatin and gemcitabine | Experimental | Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression Receives: Drug: RRx-001; Drug: Gemcitabine and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response (RECIST)
Overall objective response (RECIST)
Measured: Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start16 Jul 2015
- Primary completion10 May 2016
- Study completion25 May 2016
Why it stopped: Poor enrollment and adverse event experiences in the limited population
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 CholangiocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana De Jesus Acosta, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452970
- Sponsor's protocol ID
- RRx001-27-01
- Acronym
- EPIC
- Status last verified
- Mar 2024
- First submitted
- 17 May 2015
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
- ClinicalTrials.gov ID
- NCT02452970
- Acronym / sponsor ID
- EPIC / RRx001-27-01
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment and adverse event experiences in the limited population
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 24 Apr 2024
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 see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma.
The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred.
The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRx-001 the cisplatin and gemcitabine | Experimental | Drug: RRx-001, Drug: Gemcitabine and cisplatinPatients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma
- Must have locally advanced or distant metastatic disease that is not surgically curable
- Failed first-line chemotherapy
- Age ≥ 18 years
- Life expectancy of at least 12 weeks (3 months)
Key exclusion criteria (9 listed)
- Symptomatic metastatic brain or meningeal tumors
- Investigational compound within 4 weeks of enrollment
- History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
- Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
- Pregnant or nursing
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 |
|---|---|---|
| RRx-001RRx-001 (10 mg/m2) intravenously twice weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 30 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression | Drug | RRx-001 the cisplatin and gemcitabine |
| Gemcitabine and cisplatinRRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression | Drug | RRx-001 the cisplatin and gemcitabine |
Primary outcome
Overall Objective Response (RECIST)
Time frame: Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.
Overall objective response (RECIST)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Ana De Jesus Acosta, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RRx-001 and Gemcitabine and cisplatin in people with Cholangiocarcinoma, run by EpicentRx, Inc. at 1 site 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 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 24 Apr 2024. 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 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 phase mean?
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 24 Apr 2024). 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?
Overall Objective Response (RECIST) (time frame: Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.). 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 24 Apr 2024.