Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

NCT01359982 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RRx001-11-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RRx-001

EXPERIMENTAL

Drug: RRx-001

Interventions

RRx-001 DRUG

Dose level 1 (10 mg/m2)

RRx-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• EpicentRx, Inc.: lead

Study Sites (2)

Moores University of California San Diego Cancer Center

La Jolla, California, 92093, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 26296952 DERIVED

MeSH Terms

Conditions

Lymphoma; Neoplasms

Interventions

RRx-001

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Study Director: Bryan Oronsky, Chief Medical Officer
• Organization: EpicentRx, Inc

boronsky@epicentrx.com

8582291062

Study Officials

• Jeffrey Infante, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

• Tony Reid, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Locations

US (2)