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A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Solid Malignancies, Non-Hodgkin's Lymphoma

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Trial Information

A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

This study is for people who have advanced cancer for which standard chemotherapy did not
work or for which there are no reliably, effective treatments.

AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen
content and low blood supply; tumor areas that are usually the most resistant to standard
chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by
interfering with a protein that is required for cells to grow and divide, causing tumors to
die or to delay their growth.

All patients in this study will receive AQ4N. The dose will be increased for each new
patient or group of patients until the maximum tolerated dose is reached.

Inclusion Criteria:

- Advanced solid malignancy or non-Hodgkin’s lymphoma that is refractory to treatment
or has recurred

- Age > 18 years

- Adequate hematologic (blood), kidney and liver function

- Negative pregnancy test (females of childbearing potential only)

- Willingness to use effective contraception by both males and females throughout the
treatment period and for at least 2 months following treatment.

Exclusion Criteria:

- Any chemotherapy or radiation within the past 4 weeks

- Symptomatic or uncontrolled brain metastases (patients with history of brain
metastases who have had repeat brain scans within the past 30 days that demonstrate
no evidence of tumor progression or brain swelling and who do not require
corticosteriod treatment may be eligible)

- Significant cardiovascular illness including, but not limited to, the following:
active infection, uncontrolled hypertension, symptomatic congestive heart failure,
unstable angina pectoris, heart attack within the past six months, or uncontrolled,
irregular heart beat

- Inadequate cardiac function

- Prior investigational therapy within the past 28 days

- Pregnant or breast feeding women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Solid Malignancies
  • Non-Hodgkin's Lymphoma
  • diffuse
  • follicular
  • chronic lymphocytic leukemia
  • colorectal cancer
  • pancreatic cancer
  • acute myelogenous leukemia
  • head and neck cancer
  • breast cancer
  • prostate cancer
  • ovarian cancer
  • bladder cancer
  • hypoxia
  • refractory
  • metastatic
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Weiler Hospital of Albert Einstein College of Medicine Bronx, New York  10461
Cancer Therapy & Research Center / Institute for Drug Development San Antonio, Texas  78229