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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRx-001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RRx-001 | Drug | Dose level 1 (10 mg/m2) |
| |
| RRx-001 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Had an Adverse Events | The total number of patients who experienced at least one adverse event while receiving treatment. | From time of receiving a dose of RRx-001 through 92 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Infante, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Tony Reid, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores University of California San Diego Cancer Center | La Jolla | California | 92093 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26296952 | Derived | 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. |
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One enrolled patient had a disease-associated serious adverse event and died before starting treatment and was not included in the analysis.
Between Oct 10, 2011, and March 18, 2013, we screened 26 patients from the University of California- San Diego Moores Cancer Center, La Jolla, CA, USA, and the Sarah Cannon Research Institute, Nashville, TN, USA. 25 patients (1 ineligible) were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | RRx-001: Dose Level 1 (10 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| FG001 | RRx-001: Dose Level 2 (16.7 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| FG002 | RRx-001: Dose Level 3 (24.6 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| FG003 | RRx-001: Dose Level 4 (33 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| FG004 | RRx-001: Dose Level 5 (55.0 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| FG005 | RRx-001: Dose Level 6 (83 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RRx-001: Dose Level 1 (10 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Had an Adverse Events | The total number of patients who experienced at least one adverse event while receiving treatment. | Total number of participants enrolled | Posted | Count of Participants | Participants | From time of receiving a dose of RRx-001 through 92 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RRx-001: Dose Level 1 (10 mg/m2) to Dose Level 5 (83.0 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director: Bryan Oronsky, Chief Medical Officer | EpicentRx, Inc | 8582291062 | boronsky@epicentrx.com |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C577469 | RRx-001 |
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| Drug |
Dose Level 2 (16.7 mg/m2) |
|
| RRx-001 | Drug | Dose Level 3 (24.6 mg/m2) |
|
| RRx-001 | Drug | Dose Level 4 (33 mg/m2) |
|
| RRx-001 | Drug | Dose Level 5 (55.0 mg/m2) |
|
| RRx-001 | Drug | Dose Level 6 (83 mg/m2) |
|
| Sarah Cannon Research Institute |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Death |
|
| RRx-001: Dose Level 2 (16.7 mg/m2) |
Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG002 | RRx-001: Dose Level 3 (24.6 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG003 | RRx-001: Dose Level 4 (33 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG004 | RRx-001: Dose Level 5 (55.0 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG005 | RRx-001: Dose Level 6 (83 mg/m2) | Participants received RRx-001 by IV infusion every week for 2 Cycles. On completion, participants were offered further weekly doses, provided the Investigator and Medical Monitor agree it is warranted based on the status and symptomatology of their disease. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ECOG Status | Upon enrollment, physicians gave participants an ECOG score of 0-5. (ECOG describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Lowest score = highest functioning. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 11 |
| 25 |
| 6 |
| 25 |
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Emphysematous cholecystitis | Infections and infestations | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |