CancerPhase 1NCT00528047
Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors
A Phase 1 study testing PRLX 93936 in people with Cancer, run by Prolexys Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PRLX 93936
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Nov 2011
- 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
- Histologically confirmed solid tumors
- Tumor progression after receiving standard/approved chemotherapy and for whom no available treatment provides clinical benefit
- One or more metastatic tumors measurable on a CT scan or MRI per RECIST criteria
- ECOG performance 0-1
- Life expectancy of at least 3 months
- Age >/= 18 years
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- A negative pregnancy test (if female of child-bearing potential)
- Acceptable liver function:
- Bilirubin </= 1.5 times the Upper Limit of Normal (ULN)
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 2.5 times ULN (if liver metastases are present, then </= 5 times ULN is allowed)
- Acceptable renal function:
- Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal
- Acceptable hematologic status:
- Granulocyte count >/= 1500 cells/mm3
- Platelet count >/= 100,000 (plt/mm3)
- Hemoglobin >/= 9.0 g/dL
- Urinalysis: no clinically significant abnormalities
- Acceptable coagulation status:
- PT within normal limits
- aPTT within normal limits
- Completed any chemotherapy, major surgery, or irradiation at least four weeks before enrollment in this study (six weeks for mitomycin-C or nitrosoureas, and two weeks for "targeted" therapies such as kinase inhibitors). Patient must have recovered from all toxicities incurred as a result of previous therapy.
- QT intervals of QTC </= 450 msec for men and </= 470 msec for women (as measured by Hodges equation)
- Left ventricular ejection fraction >/= 50% by 2D Echocardiogram (or > institutional lower limits of normal)
Who cannot join
- NYHA Class III or IV, cardiac disease, myocardial infarction within the past six months, unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or nursing women
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within four weeks prior to study entry (six weeks for mitomycin-C or nitrosoureas and two weeks for targeted therapies such as kinase inhibitors).
- Unwillingness or inability to comply with protocol procedures
- Known current infection with HIV, hepatitis B or hepatitis C
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- Currently receiving any other investigational agent
- Currently receiving medications metabolized by the cytochrome P450 3A4 enzyme pathway
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with brain metastases which are well controlled (patients not taking dexamethasone or anti-seizure medication >/= three months after treatment) may be enrolled.
- Any other severe concurrent disease, which in the judgement of the investigator would make the patient inappropriate for the study
- Diagnosis of hypertension
- Previously enrolled in this trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: A Phase I, Multi-center, Open-Label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of PRLX 93936 Administered Intravenously Daily for Five Days Followed by a 23-Day Rest Period in Patients With Advanced Solid Tumors
The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies.
Read the detailed description
This study will assess the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hr daily for 5 days in patients with advanced solid tumors. Patients will be evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response will be evaluated every other cycle.
Three patients will be assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a a Dose-Limited Toxicity (DLT) is encountered. Sequential cohorts of three patients will be treated with escalating doses until the Maximum Tolerated Dose (MTD) is reached.
- Conditions
- Cancer
- Being tested
- PRLX 93936
- Keywords
- Cancer, Solid Tumor, Metastatic, Neoplasm, Malignant
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRLX 93936Drug
PRLX 93936 will be administered intravenously over one hour daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| PRLX 93936 | Experimental | Not described Receives: Drug: PRLX 93936 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical laboratory tests
Measured: Weekly
Vital signs
Measured: Daily during dosing, then weekly during followup
Electrocardiograms (ECGs)
Measured: Multiple times during dosing, then weekly during followup
Echocardiograms (ECHO)
Measured: Baseline and every other cycle
Secondary outcomes (2)
Tumor assessment
Measured: Baseline and every other cycle
Blood sampling for pharmacokinetics
Measured: Days 1 and 5 of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolexys Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Von Hoff, M.D., Principal investigator, TGen Clinical Research Services at Scottsdale HealthcarePeter J. Rosen, M.D., Principal investigator, Tower Cancer Research FoundationAndrew Wagner, M.D., Ph.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528047
- Sponsor's protocol ID
- PRLX93936-0001
- Status last verified
- Jan 2012
- First submitted
- 7 Sep 2007
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-Label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of PRLX 93936 Administered Intravenously Daily for Five Days Followed by a 23-Day Rest Period in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00528047
- Acronym / sponsor ID
- PRLX93936-0001
- Conditions
- Cancer
- Keywords
- Cancer, Solid Tumor, Metastatic, Neoplasm, Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Prolexys PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Sep 2007 (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 purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies.
Detailed description
This study will assess the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hr daily for 5 days in patients with advanced solid tumors. Patients will be evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response will be evaluated every other cycle.
Three patients will be assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a a Dose-Limited Toxicity (DLT) is encountered. Sequential cohorts of three patients will be treated with escalating doses until the Maximum Tolerated Dose (MTD) is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRLX 93936 | Experimental | Drug: PRLX 93936 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed solid tumors
- Tumor progression after receiving standard/approved chemotherapy and for whom no available treatment provides clinical benefit
- One or more metastatic tumors measurable on a CT scan or MRI per RECIST criteria
- ECOG performance 0-1
- Life expectancy of at least 3 months
Key exclusion criteria (12 listed)
- NYHA Class III or IV, cardiac disease, myocardial infarction within the past six months, unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or nursing women
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within four weeks prior to study entry (six weeks for mitomycin-C or nitrosoureas and two weeks for targeted therapies such as kinase inhibitors).
- Unwillingness or inability to comply with protocol procedures
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 |
|---|---|---|
| PRLX 93936PRLX 93936 will be administered intravenously over one hour daily for 5 days. | Drug | PRLX 93936 |
Primary outcome
Clinical laboratory tests
Time frame: Weekly
Vital signs
Time frame: Daily during dosing, then weekly during followup
Electrocardiograms (ECGs)
Time frame: Multiple times during dosing, then weekly during followup
Echocardiograms (ECHO)
Time frame: Baseline and every other cycle
2 secondary outcomes
Tumor assessment
Time frame: Baseline and every other cycle
Blood sampling for pharmacokinetics
Time frame: Days 1 and 5 of dosing
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 5 Jan 2012.
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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.
Daniel Von Hoff, M.D. principal investigator
TGen Clinical Research Services at Scottsdale Healthcare
Peter J. Rosen, M.D. principal investigator
Tower Cancer Research Foundation
Andrew Wagner, M.D., Ph.D. principal investigator
Dana-Farber Cancer Institute
3 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 PRLX 93936 in people with Cancer, run by Prolexys Pharmaceuticals at 3 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 23 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 5 Jan 2012. 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 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?
Clinical laboratory tests (time frame: Weekly). The study lists 4 primary outcomes in all. 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 5 Jan 2012.