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Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects (DINAMIC)

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ClinicalTrials.gov Identifier: NCT01359982
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
EpicentRx, Inc.

Tracking Information
First Submitted Date  ICMJE May 23, 2011
First Posted Date  ICMJE May 25, 2011
Last Update Posted Date May 20, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Number, frequency and type of adverse events [ Time Frame: 92 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Solid Tumor
  • Lymphomas
Intervention  ICMJE
  • Drug: RRx-001
    Dose level 1 (10 mg/m2)
  • Drug: RRx-001
    Dose Level 2 (16.7 mg/m2)
  • Drug: RRx-001
    Dose Level 3 (24.6 mg/m2)
  • Drug: RRx-001
    Dose Level 4 (33 mg/m2)
  • Drug: RRx-001
    Dose Level 5 (55.0 mg/m2)
  • Drug: RRx-001
    Dose Level 6 (83 mg/m2)
Study Arms  ICMJE Experimental: RRx-001
Interventions:
  • Drug: RRx-001
  • Drug: RRx-001
  • Drug: RRx-001
  • Drug: RRx-001
  • Drug: RRx-001
  • Drug: RRx-001
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2015)
26
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2011)
24
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01359982
Other Study ID Numbers  ICMJE RRx001-11-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EpicentRx, Inc.
Study Sponsor  ICMJE EpicentRx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Infante, MD SCRI Development Innovations, LLC
Principal Investigator: Tony Reid, MD University of California, San Diego
PRS Account EpicentRx, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP