CarcinomaPhase 1NCT00613691
A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma
A Phase 1 study testing SPI-1620 in people with Carcinoma, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- SPI-1620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 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
Who may be able to join
- All of the following inclusion criteria must be met prior to participation in this study
- The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments.
- The patient must be >= 18 years of age.
- The patient must have progressive or recurrent carcinoma and has failed all standard therapies for his/her tumor.
- The patient must have a negative CT scan with contrast of the brain or MRI of the brain within 45 days of enrollment.
- The patient must be using an acceptable/effective method of contraception if she is a female patient of childbearing potential.
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- The patient must have a negative serum pregnancy test within 14 days of entering the protocol if she is a female of childbearing potential.
- The patient must have an ECOG score <= 2.
- The patient must be willing and able to abide by the protocol.
Who cannot join
- None of the exclusion criteria may be met prior to patient participation in this study
- The patient has a history of CHF, migraines, coagulopathy, stroke or inadequately controlled hypertension.
- The patient has asthma or symptomatic COPD.
- The patient has autonomic nerve dysregulation syndrome.
- The patient has angina or is taking nitrates or has had a MI within the past six months.
- The patient has a significant ventricular arrhythmia, class III or IV CHF or has a known coronary stenoses >80% and has not undergone either angioplasty or CABG
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- The patient is taking phosphodiesterase inhibitors
- The patient has malignant or poorly controlled hypertension (>160/100)
- The patient has symptomatic orthostatic hypotension
- The patient is taking arterial vasodilators such as nifedipine or amlodipine or alpha blockers such as terazosin, tamsulosin and prazosin.
- The patient has a screening absolute neutrophil count less than 1.5 K/uL
- The patient has a screening platelet count less than 100 K/uL.
- The patient has a screening creatinine greater than 2.0 mg/dL
- The patient has a screening amino alanine transferase (ALT), or aspartate aminotransferase (AST) > 2.5 times the upper limit of the laboratory reference range or a total bilirubin > 1.0 mg/dL.
- The patient has a known immunodeficiency disorder.
- The patient is enrolled, or the patient plans to enroll, in any concurrent study of another investigational product.
- The patient is taking, or the patient is planning to take other cancer treatments during the study except for patients with prostate cancer using LHRH agonist therapy.
- The patient has a known hypersensitivity to any of the components of SPI 1620 or to docetaxel.
- The patient has previously failed treatment with docetaxel for his/her tumor and a dose of SPI-1620 that has been shown to enhance tumor blood flow has not been identified.
- The patient does not have a tumor that is at least 1cm. -
Trial locations and contacts
1 site in 1 country.
About this study
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.
Read the detailed description
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Eligible patients will receive SPI-1620 delivered intravenously over one minute on Days 1, 8 and 15. On Day 8 patients will undergo a series of four H215O PET Blood Flow (BF) scans which will be used to assess alterations in BF induced by SPI-1620 in tumor and non-tumor ROIs (Region of Interest). Fifteen minutes after receiving SPI-1620 on Day 15, patients will receive docetaxel, 60 mg/m2, administered by infusion over 1 hour. Accelerated dose escalation of SPI-1620 will be employed: one patient will be treated at each dose level with 100% increases between dose levels. If any grade 2 or higher, related AE occurs, the trial will revert to 3-patient cohorts with 40% dose escalation between groups. There will be no intrapatient dose escalation. Dose escalation will continue until there is either no further increase in tumor blood flow as assessed by H215O PET scan, or until significant toxicity is observed. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I. If 60 mg/m 2 was tolerated in Part I then up to six patients in Part II will receive docetaxel at a dose of 80 mg/m2 once every 3 weeks. If this is tolerated the next group of patients will receive docetaxel 100 mg/m2 once every 3 weeks.
- Conditions
- Carcinoma
- Being tested
- SPI-1620
- Keywords
- Refractory, Progressive
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-1620Drug
SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds
| Study group | Role | What they receive |
|---|---|---|
| SPI-1620 | Experimental | SPI-1620 an endothelin B agonist Receives: Drug: SPI-1620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
Measured: every three weeks
Secondary outcomes (3)
To assess the pharmacokinetic and pharmacodynamic profiles of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
Measured: one week
To identify the optimum dose of SPI-1620 to be used in future Phase II studies.
Measured: every three weeks
To assess the safety and tolerability of doses of docetaxel from 60 mg/m2 to 100 mg/m2 when given following infusion of SPI 1620.
Measured: every three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Tolcher, MD, Principal investigator, START
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613691
- Sponsor's protocol ID
- SPI-1620
- Status last verified
- Oct 2013
- First submitted
- 31 Jan 2008
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma
- ClinicalTrials.gov ID
- NCT00613691
- Acronym / sponsor ID
- SPI-1620
- Conditions
- Carcinoma
- Keywords
- Refractory, Progressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2008 (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 is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.
Detailed description
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Eligible patients will receive SPI-1620 delivered intravenously over one minute on Days 1, 8 and 15. On Day 8 patients will undergo a series of four H215O PET Blood Flow (BF) scans which will be used to assess alterations in BF induced by SPI-1620 in tumor and non-tumor ROIs (Region of Interest). Fifteen minutes after receiving SPI-1620 on Day 15, patients will receive docetaxel, 60 mg/m2, administered by infusion over 1 hour. Accelerated dose escalation of SPI-1620 will be employed: one patient will be treated at each dose level with 100% increases between dose levels. If any grade 2 or higher, related AE occurs, the trial will revert to 3-patient cohorts with 40% dose escalation between groups. There will be no intrapatient dose escalation. Dose escalation will continue until there is either no further increase in tumor blood flow as assessed by H215O PET scan, or until significant toxicity is observed. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I. If 60 mg/m 2 was tolerated in Part I then up to six patients in Part II will receive docetaxel at a dose of 80 mg/m2 once every 3 weeks. If this is tolerated the next group of patients will receive docetaxel 100 mg/m2 once every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-1620 | Experimental | Drug: SPI-1620SPI-1620 an endothelin B agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All of the following inclusion criteria must be met prior to participation in this study
- The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments.
- The patient must be >= 18 years of age.
- The patient must have progressive or recurrent carcinoma and has failed all standard therapies for his/her tumor.
- The patient must have a negative CT scan with contrast of the brain or MRI of the brain within 45 days of enrollment.
Key exclusion criteria (20 listed)
- None of the exclusion criteria may be met prior to patient participation in this study
- The patient has a history of CHF, migraines, coagulopathy, stroke or inadequately controlled hypertension.
- The patient has asthma or symptomatic COPD.
- The patient has autonomic nerve dysregulation syndrome.
- The patient has angina or is taking nitrates or has had a MI within the past six months.
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 |
|---|---|---|
| SPI-1620SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds | Drug | SPI-1620 |
Primary outcome
To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
Time frame: every three weeks
3 secondary outcomes
To assess the pharmacokinetic and pharmacodynamic profiles of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.
Time frame: one week
To identify the optimum dose of SPI-1620 to be used in future Phase II studies.
Time frame: every three weeks
To assess the safety and tolerability of doses of docetaxel from 60 mg/m2 to 100 mg/m2 when given following infusion of SPI 1620.
Time frame: every three weeks
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 21 Oct 2013.
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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.
Anthony Tolcher, MD principal investigator
START
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPI-1620 in people with Carcinoma, run by Spectrum Pharmaceuticals, Inc at 1 site 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 9 inclusion and 20 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. (time frame: every three weeks). 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 21 Oct 2013.