Malignant Solid TumorPhase 1DINAMICNCT01359982
Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects
A Phase 1 study testing RRx-001 in people with Malignant Solid Tumor and Lymphomas, run by EpicentRx, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor, Lymphomas
- What is being tested?
- RRx-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Feb 2015
- Phase
- Phase 1
- 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
- Subject is male or female, aged at least 18 years.
- Subject has a histologically or cytologically confirmed diagnosis of an advanced, malignant, incurable solid tumor(s) or lymphoma that is metastatic and/or unresectable and/or for which standard curative measures either are not applicable, or do not exist, or are no longer effective. Subjects with curative treatment options are not eligible for the protocol.
- Subject is not receiving any active treatment for his/her malignancy (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and antiandrogens such as: Flutamide, Dutasteride, and Finasteride).
- Subject's Eastern Cooperative Group (ECOG) performance status is 0, 1 or 2 at Screening.
- Subject has acceptable liver function at Screening
- Subject has a normal serum creatinine.
- Subject has acceptable hematologic status at Screening
- Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least one year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
Who cannot join
- Impaired cardiac function that in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.
- Right-to-left, bidirectional, or transient right-to-left cardiac shunts.
- Subjects with a history of acute cerebral infarction or transient ischemic attack within 90 days prior to Study Day 1.
- Acute myocardial infarction or acute coronary syndromes less than one year prior to enrollment.
- Serious ventricular arrythmias or high risk for arrhythmias due to prolongation of the QT interval.
- Subjects who experienced a major surgery, radiotherapy, or immunotherapy within the last 21 days prior to Study Day 1 (limited palliative radiation is allowed within 14 days prior to Study Day 1).
Show all 20Show fewer
- Chemotherapy regimens with delayed toxicity within the 28 days prior to Study Day 1 (except for nitrosourea or mitomycin C treatments within 42 days prior to Study Day 1).
- Chemotherapy regimens given continuously or on a weekly basis that Investigator believes to have a limited potential for delayed toxicity within 14 days prior to Study Day 1.
- Use of an investigational anti-cancer drug within 42 days prior to Study Day 1.
- Subject has symptomatic and/or untreated central nervous system metastases and/or intracranial hypertension.
- Subject has a known history of an active and/or an uncontrolled infection with hepatitis A or hepatitis B.
- Subject with a known history of a positive HIV status.
- Subjects with pulmonary edema.
- Subjects with respiratory failure
- Subjects with severe emphysema, pulmonary emboli, pulmonary fibrosis or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature.
- Subjects with Raynaud's syndrome.
- Subjects with a serious co-morbid medical condition.
- If female, subject is pregnant and/or breastfeeding.
- Any subject with congenital or acquired methemoglobinemia.
- Any subject with a history of inherited anemia or hemoglobinopathy including but not limited to hereditary spherocytosis, hereditary elliptocytosis, hereditary ovalocytosis,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Moores University of California San Diego Cancer Center
La Jolla, California, 92093
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies
The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.
Read the detailed description
The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.
- Conditions
- Malignant Solid Tumor, Lymphomas
- Being tested
- RRx-001
- Keywords
- Advanced Solid Tumors, Lymphomas, Safety, Blood flow, Nitric oxide, Cancer, Dynamic contrast enhanced MRI (DCE-MRI), Contrast Enhanced Ultrasound (CEUS)
- Medical subject headings
- Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001Drug
Dose level 1 (10 mg/m2)
RRx-001Drug
Dose Level 2 (16.7 mg/m2)
RRx-001Drug
Dose Level 3 (24.6 mg/m2)
RRx-001Drug
Dose Level 4 (33 mg/m2)
RRx-001Drug
Dose Level 5 (55.0 mg/m2)
RRx-001Drug
Dose Level 6 (83 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| RRx-001 | Experimental | Not described Receives: Drug: RRx-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Had an Adverse Events
The total number of patients who experienced at least one adverse event while receiving treatment.
Measured: From time of receiving a dose of RRx-001 through 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Infante, MD, Principal investigator, SCRI Development Innovations, LLCTony Reid, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359982
- Sponsor's protocol ID
- RRx001-11-01
- Acronym
- DINAMIC
- Status last verified
- Aug 2024
- First submitted
- 23 May 2011
- Last updated
- 1 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reid T, Oronsky B, Scicinski J, Scribner CL, Knox SJ, Ning S, Peehl DM, Korn R, Stirn M, Carter CA, Oronsky A, Taylor MJ, Fitch WL, Cabrales P, Kim MM, Burris HA Rd, Lao CD, Abrouk NED, Fanger GR, Infante JR. Safety and activity of RRx-001 in patients with advanced cancer: a first-in-human, open-label, dose-escalation phase 1 study. Lancet Oncol. 2015 Sep;16(9):1133-1142. doi: 10.1016/S1470-2045(15)00089-3. Epub 2015 Aug 19.
PubMed 26296952
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies
- ClinicalTrials.gov ID
- NCT01359982
- Acronym / sponsor ID
- DINAMIC / RRx001-11-01
- Conditions
- Malignant Solid Tumor, Lymphomas
- Keywords
- Advanced Solid Tumors, Lymphomas, Safety, Blood flow, Nitric oxide, Cancer, Dynamic contrast enhanced MRI (DCE-MRI), Contrast Enhanced Ultrasound (CEUS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 1 Nov 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 evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.
Detailed description
The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.
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 | Experimental | Drug: RRx-001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male or female, aged at least 18 years.
- Subject has a histologically or cytologically confirmed diagnosis of an advanced, malignant, incurable solid tumor(s) or lymphoma that is metastatic and/or unresectable and/or for which standard curative measures either are not applicable, or do not exist, or are no longer effective. Subjects with curative treatment options are not eligible for the protocol.
- Subject is not receiving any active treatment for his/her malignancy (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and antiandrogens such as: Flutamide, Dutasteride, and Finasteride).
- Subject's Eastern Cooperative Group (ECOG) performance status is 0, 1 or 2 at Screening.
- Subject has acceptable liver function at Screening
Key exclusion criteria (20 listed)
- Impaired cardiac function that in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.
- Right-to-left, bidirectional, or transient right-to-left cardiac shunts.
- Subjects with a history of acute cerebral infarction or transient ischemic attack within 90 days prior to Study Day 1.
- Acute myocardial infarction or acute coronary syndromes less than one year prior to enrollment.
- Serious ventricular arrythmias or high risk for arrhythmias due to prolongation of the QT interval.
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-001Dose level 1 (10 mg/m2) | Drug | RRx-001 |
| RRx-001Dose Level 2 (16.7 mg/m2) | Drug | RRx-001 |
| RRx-001Dose Level 3 (24.6 mg/m2) | Drug | RRx-001 |
| RRx-001Dose Level 4 (33 mg/m2) | Drug | RRx-001 |
| RRx-001Dose Level 5 (55.0 mg/m2) | Drug | RRx-001 |
| RRx-001Dose Level 6 (83 mg/m2) | Drug | RRx-001 |
Primary outcome
Number of Patients Who Had an Adverse Events
Time frame: From time of receiving a dose of RRx-001 through 92 days
The total number of patients who experienced at least one adverse event while receiving treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26296952Reid T, Oronsky B, Scicinski J, Scribner CL, Knox SJ, Ning S, Peehl DM, Korn R, Stirn M, Carter CA, Oronsky A, Taylor MJ, Fitch WL, Cabrales P, Kim MM, Burris HA Rd, Lao CD, Abrouk NED, Fanger GR, Infante JR. Safety and activity of RRx-001 in patients with advanced cancer: a first-in-human, open-label, dose-escalation phase 1 study. Lancet Oncol. 2015 Sep;16(9):1133-1142. doi: 10.1016/S1470-2045(15)00089-3. Epub 2015 Aug 19.
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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.
Jeffrey Infante, MD principal investigator
SCRI Development Innovations, LLC
Tony Reid, MD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RRx-001 in people with Malignant Solid Tumor and Lymphomas, run by EpicentRx, Inc. at 2 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Yes. Results are posted in the registry (first posted 1 Nov 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?
Number of Patients Who Had an Adverse Events (time frame: From time of receiving a dose of RRx-001 through 92 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359982, which also lists 1 linked publication.
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 1 Nov 2024.