Suspended

AQ4N for Advanced Malignancies Resistant to Standard Chemotherapy

What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+61

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 2004

See protocol details

Summary

Principal SponsorNovacea

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on individuals with advanced cancers that have not responded to standard chemotherapy or for which no reliable treatments exist. The study aims to test an experimental chemotherapy drug called AQ4N. This drug is unique as it targets areas of the tumor with low oxygen and poor blood supply, areas that are typically resistant to standard chemotherapy and radiation treatments. The potential benefit of AQ4N is that it may interfere with a protein necessary for cell growth and division, potentially causing tumors to die or slow their growth. All participants in this study will receive AQ4N via intravenous administration. The dose will be gradually increased for each new patient or group of patients. This continuation will occur until the maximum tolerated dose is identified. The study measures the results by evaluating how well the participants tolerate the increasing doses of AQ4N.

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

NCT00090727

Principal SponsorNovacea

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesHypoxiaUrinary Bladder DiseasesUrinary Bladder NeoplasmsBreast DiseasesBreast NeoplasmsChronic DiseaseColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHead and Neck NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersIntestinal DiseasesIntestinal NeoplasmsLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesOvarian DiseasesOvarian NeoplasmsPancreatic DiseasesPancreatic NeoplasmsPathologic ProcessesProstatic DiseasesProstatic NeoplasmsRectal DiseasesSigns and SymptomsSigns and Symptoms, RespiratorySkin DiseasesPathological Conditions, Signs and SymptomsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsColorectal NeoplasmsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteSkin and Connective Tissue DiseasesDisease AttributesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate

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)

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6 exclusion criteria prevent from participating

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

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Weiler Hospital of Albert Einstein College of Medicine

The Bronx, United StatesOpen Weiler Hospital of Albert Einstein College of Medicine in Google Maps

Suspended

Cancer Therapy & Research Center / Institute for Drug Development

San Antonio, United States

Suspended2 Study Centers