Liver NeoplasmsPhase 1NCT00094003
Study of NS-9 in Patients With Liver Metastases
A Phase 1 study testing NS-9 [Poly I: Poly C] in people with Liver Neoplasms and Neoplasm Metastasis, run by NS Pharma, Inc. at 2 sites in United States.
Trial summary
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Neoplasm Metastasis, Local Neoplasm Recurrences
- What is being tested?
- NS-9 [Poly I: Poly C]
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to not given
- 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
- Male and female at least 18 years of age.
- Patients with liver metastases from various primary cancers for which no other curative treatment options exist.
- At least one measurable lesion (by CT or MRI)
- Life expectancy > 3 months
- Child-bearing potential women must have a negative serum pregnancy test
- ECOG performance status: 0-1
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- Fully recovered from any previous cancer therapy or infection (at least 4 weeks from radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at least 2 weeks from an exploration/biopsy)
- Discontinued from any other investigational drug for at least 30 days
- Serum calcium <11 mg/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support
- Hemoglobin ≥9.0 g/dL
- Platelet count ≥100,000/mm3
- Serum creatinine ≤1.5 times the upper limit of normal (ULN)
- Bilirubin ≤1.5 times ULN
- ALT and AST ≤3 times ULN
- Amylase and lipase ≤ ULN
- PT and PTT < 1.5 times ULN
- ECG with no acute abnormalities
- Afebrile (≤37.5C or 99.5F)
- Willingness and ability to comply with all study requirements
Who cannot join
- Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.
- Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).
- History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).
- New York Heart Association classification Class III or IV
- Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.
- Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.
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- Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.
- Subject has received radiation to >25% of the total bone marrow.
- Subject has a history of any other illness that would preclude study participation.
- Subject has brain metastases.
- Subject has allergy to egg yolk.
- Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.
Read the detailed description
This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.
After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.
- Being tested
- NS-9 [Poly I: Poly C]
- Keywords
- Liver metastases, Colorectal cancer, Gastric cancer, Esophagus cancer, Breast cancer, Lung cancer, Skin cancer, Renal Cancer, Liver metastasis
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-9 [Poly I: Poly C]Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study startSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- NS Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094003
- Sponsor's protocol ID
- NS9001
- Status last verified
- Nov 2005
- First submitted
- 8 Oct 2004
- Last updated
- 11 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
- ClinicalTrials.gov ID
- NCT00094003
- Acronym / sponsor ID
- NS9001
- Keywords
- Liver metastases, Colorectal cancer, Gastric cancer, Esophagus cancer, Breast cancer, Lung cancer, Skin cancer, Renal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- NS Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- First posted
- 11 Oct 2004 (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.
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.
Detailed description
This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.
After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.
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 (20 listed)
- Male and female at least 18 years of age.
- Patients with liver metastases from various primary cancers for which no other curative treatment options exist.
- At least one measurable lesion (by CT or MRI)
- Life expectancy > 3 months
- Child-bearing potential women must have a negative serum pregnancy test
Key exclusion criteria (12 listed)
- Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.
- Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).
- History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).
- New York Heart Association classification Class III or IV
- Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.
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 |
|---|---|---|
| NS-9 [Poly I: Poly C] | 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 11 Nov 2005.
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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.
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 NS-9 [Poly I: Poly C] in people with Liver Neoplasms and Neoplasm Metastasis, run by NS Pharma, Inc. at 2 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 20 inclusion and 12 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 11 Nov 2005. 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 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 11 Nov 2005.