Clinical trial · Interventional
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer
NCT00575393CI-TRIAL-00035184completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium thiomalate in treating patients with advanced non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorine F 18 fluorothymidine | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| gold sodium thiomalate | Drug | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Maximum tolerated dose
- measure
- Toxicity
- measure
- Biologic activity
- measure
- Correlate PKCl expression with antitumor effects of gold sodium thiomalate
- measure
- Correlate toxicity and/or tumor response or activity with pharmacokinetic and pharmacodynamic parameters
- measure
- Anti-proliferative activity of gold sodium thiomalate by PET scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced non-small cell lung cancer * No known standard therapy for disease that is potentially curative or definitely capable of extending life expectancy * No symptomatic or worsening CNS metastases despite optimal therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/µL * Platelet count ≥ 100,000/µL * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 3 times ULN (5 times ULN if liver involvement) * Creatinine ≤ 1.2 times ULN * Hemoglobin ≥ 9.0 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be willing to provide blood and tissue samples * No uncontrolled infection * No New York Heart Association class III or IV heart disease * No known allergy to gold sodium thiomalate PRIOR CONCURRENT THERAPY: * Recovered from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * No prior chemotherapy within the past 3 weeks * No prior mitomycin C or nitrosoureas within the past 6 weeks * No prior immunotherapy within the past 3 weeks * No prior biologic therapy within the past 3 weeks * No prior radiotherapy within the past 3 weeks * No prior radiotherapy to \> 25% of bone marrow * No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation) * No concurrent prophylactic colony stimulating factors
References
Publications (0)
Data not yet available
No reference posted for this study.