Clinical trial · Interventional
GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy
A Cancer Research UK Phase I Trial of 4-(N-(S-Glutathionylacetyl) Amino) Phenylarsenoxide (GSAO) Given as Daily Intravenous Infusions on Days 1-5 and 8-12 of a 21-Day Cycle, to Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| angiogenesis inhibitor GSAO | Drug | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose-limiting toxicity
- measure
- Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
Secondary outcomes (5)
- measure
- Relationship between pharmacokinetics and toxicity and/or markers of efficacy
- measure
- Changes in microvascular function using DCE-MRI
- measure
- Plasma and tumor levels of angiogenic factors and apoptosis markers
- measure
- Response (stable disease, partial response, or complete response) as determined by RECIST criteria
- measure
- Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor * Refractory to conventional treatment or for which no conventional therapy exists * Disease assessable by DCE-MRI and should be of a size that can be adequately assessed by these techniques * No known primary brain tumors or brain metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy ≥ 12 weeks * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100 x 10\^9/L * Neutrophil count ≥ 1.5 x 10\^9/L * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * Creatinine clearance ≥ 50 mL/min (uncorrected value) * Serum potassium and magnesium normal * No proteinuria \> grade 1 either on 24-hour urine or on 2 consecutive dipsticks taken no less than 1 week apart * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy * Not at high medical risk due to non-malignant systemic disease, including active uncontrolled infection * No serologically positive hepatitis B, hepatitis C, or HIV * No concurrent congestive heart failure or prior NYHA class III-IV cardiac disease * None of the following medical conditions: * Angina (stable or severe, even if well controlled on medication) * Myocardial infarction in the past 2 months by ECG * Congestive cardiac failure * Arrhythmias, including any condition associated with QTc prolongation (e.g., Lange-Neilson syndrome or Romano Ward syndrome) * Evidence of ischemia * QTc \> 480 msec * Other clinically significant abnormalities * No uncontrolled hypertension (defined as BP consistently greater than 160/100 mm Hg irrespective of medication) * No other condition that, in the opinion of the investigator, would not make the patient a good candidate for this clinical trial * No pacemakers * No metal fragments in the eyes or shrapnel or bullet injuries PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior treatments (except for alopecia or certain grade 1 toxicities which, in the opinion of the investigator and Cancer Research UK, should not exclude the patient) * At least 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for nitrosoureas and mitomycin C) * At least 1 week since prior and no concurrent shellfish * At least 6 weeks since prior major surgery (including thoracic and/or abdominal surgery) and recovered * Concurrent luteinizing-hormone releasing-hormone (LHRH) analogues allowed for patients with castration-refractory prostate cancer provided the prostate-specific antigen level is rising * No prior heart or brain surgery * No concurrent drug known to prolong the QTc interval * No concurrent warfarin (1 mg for maintenance of a Hickman line is acceptable) or heparin (flushing of arterial lines, if necessary, is acceptable) * No concurrent naproxen (other NSAIDs are acceptable) * No concurrent prophylactic use of antiemetics during the first treatment * Domperidone and lorazepam must not be used as antiemetics * No other concurrent anticancer therapy or investigational drugs * Concurrent bisphosphonates allowed
References
Publications (0)
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