NeoplasmsPhase 1NCT00390676
A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine
A Phase 1 study testing ADH -1 and carboplatin, ADH -1 and docetaxel and ADH -1 and capecitabine in people with Neoplasms, run by Adherex Technologies, Inc. at 10 sites in United States.
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 the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with… 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 and carboplatin, ADH -1 and docetaxel and ADH -1 and capecitabine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Nov 2006to Nov 2009
- 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
Who may be able to join
- Signed written informed consent
- Male and female patients > or = 18 years of age with a solid tumor(s) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate
- Measurable disease
- Immunohistochemical evidence of N-cadherin expression in tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG
Who cannot join
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- History of spinal cord compression, or history of primary brain tumor(s) 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 tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
- Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New York Oncology Hematology P.C.
Albany, New York, 12208
Texas Oncology, PA
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Dayton Oncology & Hematology, P.A
Kettering, Ohio, 45409
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida
Ocoee, Florida, 34761
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, 98684
About this study
Official title: A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)
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 the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.
- Conditions
- Neoplasms
- Being tested
- ADH -1 and carboplatin, ADH -1 and docetaxel, ADH -1 and capecitabine
- Keywords
- cancer, tumors, anticarcinogenic agents, antineoplastic agents, cadherins, solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADH -1 and carboplatinDrug
ADH -1 and docetaxelDrug
ADH -1 and capecitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startNov 2006
- Study completionNov 2009
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
- 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)
- Collaborators
- US Oncology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390676
- Sponsor's protocol ID
- AHX-01-006
- Status last verified
- Dec 2010
- First submitted
- 18 Oct 2006
- 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
- A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)
- ClinicalTrials.gov ID
- NCT00390676
- Acronym / sponsor ID
- AHX-01-006
- Conditions
- Neoplasms
- Keywords
- cancer, tumors, anticarcinogenic agents, antineoplastic agents, cadherins, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Adherex Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Study start
- Nov 2006
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Oct 2006 (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 the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.
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) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate
- Measurable disease
- Immunohistochemical evidence of N-cadherin expression in tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG
Key exclusion criteria (6 listed)
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- History of spinal cord compression, or history of primary brain tumor(s) 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 tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
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 and carboplatin | Drug | – |
| ADH -1 and docetaxel | Drug | – |
| ADH -1 and capecitabine | 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.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
10 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 ADH -1 and carboplatin, ADH -1 and docetaxel and ADH -1 and capecitabine in people with Neoplasms, run by Adherex Technologies, Inc. at 10 sites in United States.
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 6 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 10 sites in United States. 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 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.