Clinical trial · Interventional
Treatment of Advanced Renal Cell Carcinoma With Quinacrine
An Open-label, Fixed-dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
NCT00574483CI-TRIAL-00018740withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): reevaluation of compound development
Summary
Brief summary (as posted)
The overall response to standard therapies and to the newer antiangiogenesis therapies is not curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation of therapies, with different mechanisms of action, is needed for patients with metastatic RCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quinacrine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Unblinded treatment arm
- interventionNames
- Drug: quinacrine
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Time to tumor progression
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed RCC with clear cell predominance. * Subjects must provide written informed . * Subjects must be at least 18 years old. * Subjects must have at least 1 measurable lesion. * Subjects must have metastatic, locally advanced or unresectable RCC. * Subjects must have received ≥ 1 prior systemic regimen for RCC. * All prior cancer therapy, including radiation, surgery, and systemic (hormonal, chemotherapeutic, and immunotherapeutic) therapy, must be completed at least 4 weeks before the baseline visit. * Subjects must be capable of adhering to the study visit schedule and other protocol requirements. * Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Subjects must have: 1. Absolute neutrophil count (ANC)\> 1,500/uL 2. Hemoglobin \> 10.0 g/dL 3. Platelets ≥ 100,000/uL 4. Serum creatinine \< 2.0 mg/dL * Subjects must have adequate hepatic function, as defined by a bilirubin level of ≤ 1.5 times the upper limit of the normal range (ULN) and an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level of ≤ 3 times the ULN (or ≤ 5 times the ULN if liver metastases are present). * Women of childbearing potential must have a negative serum pregnancy test at the screening visit and throughout the study. * Sexually active women and men must agree to use a medically acceptable form of contraception. Exclusion Criteria: * Subjects who have a history of any malignancy (other than excised basal cell carcinoma or cervical intraepithelial neoplasia) within the 5 years of baseline visit. * Subjects who have received any anticancer agents, treatment (chemotherapy, targeted agents, radiation, hormones), or investigational agents within 30 days of the baseline visit. * Subjects who have untreated brain metastases. * Subjects who have a history of hypersensitivity reaction to quinacrine or other acridine derivatives (e.g. Cognex). * Subjects who have any clinically significant hematological, endocrine, cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal (GI), or neurological disease (including any history of seizure). * Subjects who have a history of porphyria or psoriasis. * Subjects who have documented glucose-6-phosphate dehydrogenase deficiency. * Subjects who have a history of noninfectious (toxic, autoimmune) hepatitis. * Subjects who have a history of schizophrenia, bipolar disorder, or any psychiatric illness/social situations that would limit compliance with study requirements. * Subjects who have a history of dermatitis as an allergic/toxic reaction to any medication. * Subjects who have any grade 2 sensory neuropathy. * Subjects who have a QTcF (Fredericia) of \> 450 msec. * Subjects who have New York Heart Association (NYHA) class 3 or 4 heart failure. * Subjects who had a myocardial infarction or acute coronary syndrome within 6 months of the baseline visit. * Subjects who require anti-arrhythmic treatment with amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning Automatic Implantable Cardio-Defibrillator (AICD) implanted. * Subjects who are immunocompromised, including those known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
References
Publications (0)
Data not yet available
No reference posted for this study.