NeoplasmsPhase 1/2NCT00265057
Study of ADH-1 Given Intravenously to Patients With Solid Tumors
A Phase 1/2 study testing ADH -1 (Exherin™) in people with Neoplasms, run by Adherex Technologies, Inc. at 3 sites in 2 countries.
Trial summary
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- ADH -1 (Exherin™)
- How many people
- Not given
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2005to Jan 2008
- Phase
- Phase 1/2
- 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
Who may be able to join
- Signed written informed consent
- Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.
- Clinically or radiologically documented measurable disease.
- Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
Who cannot join
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
- History of primary brain tumors or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months. History of spinal cord compression. History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry
- History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, 20133
Instituto Europeo di Oncologia
Milan, 20141
Switzerland1 site
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
About this study
Official title: Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Weekly in 3 Week Cycles by Intravenous Infusion in Patients With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX-01-004)
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.
- Conditions
- Neoplasms
- Being tested
- ADH -1 (Exherin™)
- Keywords
- Cancer;, Tumors;, Neoplasms;, Anticarcinogenic Agents;, Antineoplastic Agents;, Cadherins;, Non-Small-Cell Lung Carcinoma;, Ovarian Cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADH -1 (Exherin™)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startJun 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Adherex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265057
- Sponsor's protocol ID
- Adherex Protocol # AHX-01-004
- Status last verified
- Dec 2010
- First submitted
- 13 Dec 2005
- Last updated
- 28 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Weekly in 3 Week Cycles by Intravenous Infusion in Patients With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX-01-004)
- ClinicalTrials.gov ID
- NCT00265057
- Acronym / sponsor ID
- Adherex Protocol # AHX-01-004
- Conditions
- Neoplasms
- Keywords
- Cancer;, Tumors;, Neoplasms;, Anticarcinogenic Agents;, Antineoplastic Agents;, Cadherins;, Non-Small-Cell Lung Carcinoma;, Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Adherex Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Dec 2005 (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.
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent
- Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.
- Clinically or radiologically documented measurable disease.
- Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
Key exclusion criteria (5 listed)
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
- History of primary brain tumors or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months. History of spinal cord compression. History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry
- History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
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 |
|---|---|---|
| ADH -1 (Exherin™) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Adherex Technologies Inc. Corporate HomepageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADH -1 (Exherin™) in people with Neoplasms, run by Adherex Technologies, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Switzerland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 28 Dec 2010.