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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

Phase 1
18 Years
Open (Enrolling)
Malignant Solid Tumor, Lymphomas

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Trial Information

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 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.

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

- 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 TIAs within 90 days prior to
Study Day 1.

- Acute myocardial infarction or acute coronary syndromes less than one year prior to

- 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

- 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

- 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 spherosytosis, hereditary elliptocytosis, hereditary

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number, frequency and type of adverse events

Outcome Time Frame:

92 days

Safety Issue:


Principal Investigator

Jeffrey Infante, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Malignant Solid Tumor
  • Lymphomas
  • Advanced Solid Tumors
  • Lymphomas
  • Safety
  • Blood flow
  • Nitric oxide
  • Cancer
  • Dynamic contrast enhanced MRI (DCE-MRI)
  • Contrast Enhanced Ultrasound (CEUS)
  • Lymphoma
  • Neoplasms



Sarah Cannon Research Institute Nashville, Tennessee  37203
Moores University of California San Diego Cancer Center LA Jolla, California  92093