---
title: Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas
nct_id: NCT00955292
overall_status: TERMINATED
phase: PHASE1
sponsor: Cylene Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Advanced Solid Tumors
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00955292.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00955292"
ct_last_update_post_date: 2009-08-10
last_seen_at: "2026-05-12T07:20:14.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas

**Official Title:** A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas

**NCT ID:** [NCT00955292](https://clinicaltrials.gov/study/NCT00955292)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Modified dose schedule presented no advantage over previously studied schedule
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Cylene Pharmaceuticals
- **Conditions:** Advanced Solid Tumors, Lymphoma
- **Start Date:** 2007-07
- **Completion Date:** 2008-12
- **CT.gov Last Update:** 2009-08-10

## Brief Summary

This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.

## Detailed Description

Quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. Quarfloxin was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with histologically confirmed solid tumors or lymphomas.
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
* One or more tumors measurable on radiograph or CT scan, or evaluable disease (e.g., malignant ascites).
* Karnofsky performance status of greater than or equal to 70.
* Life expectancy of at least 3 months.
* Age at least 18 years.
* Patients must have central IV access, or agree to the insertion of a central IV line.
* Normal oxygen saturation by pulse oximetry on room air
* A negative pregnancy test (if female).
* Acceptable liver function as evaluated by laboratory results
* Acceptable renal function as evaluated by laboratory results
* Acceptable hematologic status as evaluated by laboratory results
* No clinically significant urinalysis abnormalities
* Acceptable coagulation status as evaluated by laboratory results
* Fertile men and women must use effective contraceptive methods during the study.

Exclusion Criteria:

* Seizure disorders requiring anticonvulsant therapy.
* Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months).
* Severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable pulmonary compromise.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Pregnant or nursing women.
* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Unwillingness or inability to comply with procedures required in this protocol.
* Known infection with HIV, hepatitis B, or hepatitis C.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who are currently receiving any other investigational agent.
* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.
```

## Arms

- **Quarfloxin** (EXPERIMENTAL)

## Interventions

- **Quarfloxin** (DRUG) — Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

## Primary Outcomes

- **Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)** _(time frame: Cycle 1)_
- **Recommended Phase 2 dose** _(time frame: Cycle 1)_

## Secondary Outcomes

- **Pharmacokinetics (PK) in humans of intravenously administered quarfloxin** _(time frame: One month)_
- **Evaluation of antitumor activity of quarfloxin by objective radiologic assessment** _(time frame: Every 2 months)_
- **Pharmacodynamic evaluation of antitumor activity** _(time frame: Monthly)_

## Locations (2)

- Scottsdale, Arizona, United States
- San Antonio, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.|san antonio|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00955292.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00955292*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*