TumorsPhase 1NCT00255333
INNO-105 in Patients With Solid Tumors
A Phase 1 study testing INNO-105 in people with Tumors, run by Innovive Pharmaceuticals at 2 sites in United States.
Trial summary
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- INNO-105
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Mar 2007
- 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
- Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
- Be ≥18 years old.
- Not eligible for effective therapy likely to provide clinical benefit.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Acceptable pretreatment clinical laboratory results.
- Life expectancy of greater than 12 weeks.
Who cannot join
- Have received previous treatment with INNO-105.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- Have symptomatic or untreated central nervous system (CNS) metastases.
- Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Mary Crowley Medical Research Center
Dallas, Texas, 75201
About this study
Official title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.
- Conditions
- Tumors
- Being tested
- INNO-105
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-105Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2005 (estimated)
- Study startNov 2005
- Study completionMar 2007
Why it stopped: Development of this compound was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- 24 participants
Sponsor and investigators
- Lead sponsor
- Innovive Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Casey Cunningham, MD, Principal investigator, Mary Crowley Medical Research CenterEdward Sausville, M.D., Ph.D., Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255333
- Sponsor's protocol ID
- INNO-105-901
- Status last verified
- May 2007
- First submitted
- 16 Nov 2005
- Last updated
- 14 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00255333
- Acronym / sponsor ID
- INNO-105-901
- Conditions
- Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of this compound was discontinued.
- Enrolment
- 24 participants
- Lead sponsor
- Innovive PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Nov 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.
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.
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 (6 listed)
- Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
- Be ≥18 years old.
- Not eligible for effective therapy likely to provide clinical benefit.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Acceptable pretreatment clinical laboratory results.
Key exclusion criteria (8 listed)
- Have received previous treatment with INNO-105.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
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 |
|---|---|---|
| INNO-105 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Development of this compound was discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2007.
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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.
Casey Cunningham, MD principal investigator
Mary Crowley Medical Research Center
Edward Sausville, M.D., Ph.D. principal investigator
University of Maryland Greenebaum Cancer Center
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 INNO-105 in people with Tumors, run by Innovive Pharmaceuticals 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 May 2007. 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 was stopped early (reason given: Development of this compound was discontinued.). 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.
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 14 May 2007.