Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01147029
GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy
A Phase 1 study testing angiogenesis inhibitor GSAO, laboratory biomarker analysis and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Research UK at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- angiogenesis inhibitor GSAO, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2008to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Christie Hospital
Manchester, England, M20 4BX
Churchill Hospital
Oxford, England, OX3 7LJ
About this study
Official title: 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
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.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
- To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
Secondary
- To determine the pharmacokinetics of this drug in these patients.
- To determine the pharmacodynamics of this drug in these patients.
- To determine possible anti-tumor activity in patients treatment with this drug.
Tertiary
- To further determine the pharmacodynamics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive angiogenesis inhibitor GSAO IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients showing clinical benefit (i.e., stable disease, partial response, or complete response) may receive 6 additional courses of treatment. Patients receive angiogenesis inhibitor GSAO IV over 1 hour on day -7 to obtain pharmacokinetics information of a single IV dose of the drug.
Patients also undergo dynamic contrast-enhanced magnetic-resonance imaging (DCE-MRI) prior to, during, and after study to determine blood flow parameters.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker studies.
After completion of study treatment, patients are followed up for 28 days and then once a month thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Being tested
- angiogenesis inhibitor GSAO, laboratory biomarker analysis, pharmacological study, dynamic contrast-enhanced magnetic resonance imaging
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiogenesis inhibitor GSAODrug
laboratory biomarker analysisOther
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
Secondary outcomes (5)
Relationship between pharmacokinetics and toxicity and/or markers of efficacy
Changes in microvascular function using DCE-MRI
Plasma and tumor levels of angiogenic factors and apoptosis markers
Response (stable disease, partial response, or complete response) as determined by RECIST criteria
Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2008
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Jayson, MD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147029
- Sponsor's protocol ID
- CDR0000675271
- Other IDs
- CRUK-PH1-109, EUDRACT-2006-002326-34, CTA-21106-0222-001
- Status last verified
- Apr 2012
- First submitted
- 17 Jun 2010
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01147029
- Acronym / sponsor ID
- CDR0000675271
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
- To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
Secondary
- To determine the pharmacokinetics of this drug in these patients.
- To determine the pharmacodynamics of this drug in these patients.
- To determine possible anti-tumor activity in patients treatment with this drug.
Tertiary
- To further determine the pharmacodynamics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive angiogenesis inhibitor GSAO IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients showing clinical benefit (i.e., stable disease, partial response, or complete response) may receive 6 additional courses of treatment. Patients receive angiogenesis inhibitor GSAO IV over 1 hour on day -7 to obtain pharmacokinetics information of a single IV dose of the drug.
Patients also undergo dynamic contrast-enhanced magnetic-resonance imaging (DCE-MRI) prior to, during, and after study to determine blood flow parameters.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker studies.
After completion of study treatment, patients are followed up for 28 days and then once a month thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angiogenesis inhibitor GSAO | Drug | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure or surgery | – |
Primary outcome
Dose-limiting toxicity
Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
5 secondary outcomes
Relationship between pharmacokinetics and toxicity and/or markers of efficacy
Changes in microvascular function using DCE-MRI
Plasma and tumor levels of angiogenic factors and apoptosis markers
Response (stable disease, partial response, or complete response) as determined by RECIST criteria
Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Jayson, MD principal investigator
The Christie NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing angiogenesis inhibitor GSAO, laboratory biomarker analysis and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Research UK at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.