Solid TumorsPhase 1NCT00710697
Cardiac Safety Assessment Study of Picoplatin in Solid Tumors
A Phase 1 study testing Picoplatin in people with Solid Tumors, run by Poniard Pharmaceuticals at 7 sites in United States.
Trial summary
The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Picoplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2008to Jul 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
- Documented histological or cytological diagnosis of non-hematological malignancy.
- Subjects for whom, in the opinion of the investigator, treatment with single agent picoplatin is appropriate.
- 18 years of age or older.
- ECOG performance status 0-2.
- An acceptable screening ECG.
- The following laboratory values:
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- ANC ≥ 1500 cells/mm3 (without use of myeloid growth factors).
- Hemoglobin ≥ 10.0 g/dL (may be achieved with transfusion or growth factors).
- Platelet count ≥ 100,000/mm3 (without platelet transfusions in the past 10 days).
- Serum creatinine ≤ 1.5 x ULN.
- Total bilirubin ≤ 1.5 x ULN.
- AST/SGOT and ALT/SGPT ≤ 2.5 x ULN (up to 5.0 x ULN in the event of documented hepatic tumor involvement).
- Serum potassium and magnesium within institutional normal limits. PT, aPTT ≤ 1.2 x ULN.
- Recovery period ≥ 4 weeks since major surgery, any chemotherapy (≥ 6 weeks for treatment with mitomycin or any nitrosourea), any biological therapy, any investigational therapy or any change in usage of "alternative therapies".
- Recovery period ≥ 2 weeks since any radiation therapy.
- Willing, available and able to comply with all protocol requirements including dietary schedule and restrictions.
- Written informed consent obtained prior to any screening procedures.
Who cannot join
- Symptomatic or uncontrolled brain metastases.
- Use of conventional granulocyte growth factors within the preceding 10 days or pegfilgrastim within the past 21 days.
- Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example,
- Unresolved toxicities from prior treatments of > Grade 1 (other than alopecia).
- Clinically significant infection.
- Known viral infections with hepatitis B or C or HIV.
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- Clinically significant psychiatric illness.
- Any other systemic or localized disease or therapy likely to interfere with tolerance of chemotherapy or requirements of study participation.
- History of unexplained syncope within the last two months or a family history of sudden unexplained death.
- Cardiac contraindications to study participation, including:
- History of serious cardiac disease, defined as myocardial infarction within three months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, clinically significant cardiac arrhythmias, poorly controlled or unstable angina or electrocardiographic evidence of acute ischemia.
- Implantable pacemaker or automatic implantable cardioverter defibrillator.
- Congenital long QT syndrome or family history of long QT syndrome.
- If male, QTc > 450 ms; if female, QTc > 460 ms.
- PR duration > 240 ms; QRS > 110 ms. Complex arrhythmias (significant ventricular tachycardia, Mobitz block, bifascicular AV block) on the screening ECG.
- Atrial fibrillation or flutter. Complete left bundle branch block; use of an obligate pacemaker.
- Current use of anticoagulants or anti-platelet drugs, including aspirin, warfarin, enoxaparin, clopidogrel, or heparin (use of heparin for central venous port maintenance is acceptable).
- Ongoing bleeding or history of clinically significant bleeding within the last 6 months (unless the etiology of the prior bleeding has been identified and corrected).
- Concurrent medications that prolong the QT interval (including cisapride, erythromycin, antipsychotics or tricyclic antidepressants, quinidine, procainamide, disopyramide, amiodarone or sotalol), or any agent classified as either "Drugs with Risk of Torsades de Pointes" or "Drugs with Possible Risk of Torsades de Pointes" on the website www.torsades.org.
- Female subjects who are pregnant or breast feeding.
- Subjects of reproductive potential not willing to use an effective method of contraception during the study (from first day of and until 1 month after study drug administration).
- Conditions that may interfere with QTc analysis:
- Allergy to ECG electrodes.
- Any condition that impairs the placement of ECG electrodes or the interpretation of ECGs (including but not limited to breast implants).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UNM Cancer Center
Albuquerque, New Mexico, 87131
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Moores UCSD Cancer Center
La Jolla, California, 92093
Premiere Oncology
Santa Monica, California, 90404
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258
Swedish Cancer Institute
Seattle, Washington, 98104
Northwest Medical Specialities
Tacoma, Washington, 98405
About this study
Official title: A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization
The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.
Read the detailed description
Phase 1 and 2 studies have demonstrated that picoplatin, a next-generation platinum analogue designed to avoid drug resistance, has activity when administered IV in a variety of cancers. Preclinical and clinical studies indicate that picoplatin may be effective in platinum refractory or resistant cancer.
Preclinical data in beagle dogs have shown that picoplatin had no effect on cardiovascular function, including the QT interval. In the cumulative human trial experience, the cardiovascular serious adverse events that have occurred are consistent with events expected in patients with advanced malignant disease and do not suggest any propensity toward drug-related serious ventricular arrhythmias or sudden death.
The purpose of this trial is to conduct a formal study to specifically evaluate the effect of picoplatin on the QT/QTc interval as measured by the ECG, and to correlate QTcF interval with plasma total and ultrafilterable platinum concentrations. This study is also being conducted to ensure the safety of picoplatin with regard to the QT/QTc interval. Patients who choose to participate in this study will also be given the opportunity to continue to receive picoplatin until limited by toxicity or disease progression.
- Conditions
- Solid Tumors
- Being tested
- Picoplatin
- Keywords
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostrate Cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoplatinDrug
IV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Picoplatin Receives: Drug: Picoplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG interval change
Measured: 24 hours
Secondary outcomes (1)
Safety/Efficacy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poniard Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Earhart, MD, PhD, Study director, Poniard Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710697
- Sponsor's protocol ID
- 0701
- Status last verified
- Sep 2009
- First submitted
- 2 Jul 2008
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization
- ClinicalTrials.gov ID
- NCT00710697
- Acronym / sponsor ID
- 0701
- Conditions
- Solid Tumors
- Keywords
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Poniard PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Jul 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.
The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.
Detailed description
Phase 1 and 2 studies have demonstrated that picoplatin, a next-generation platinum analogue designed to avoid drug resistance, has activity when administered IV in a variety of cancers. Preclinical and clinical studies indicate that picoplatin may be effective in platinum refractory or resistant cancer.
Preclinical data in beagle dogs have shown that picoplatin had no effect on cardiovascular function, including the QT interval. In the cumulative human trial experience, the cardiovascular serious adverse events that have occurred are consistent with events expected in patients with advanced malignant disease and do not suggest any propensity toward drug-related serious ventricular arrhythmias or sudden death.
The purpose of this trial is to conduct a formal study to specifically evaluate the effect of picoplatin on the QT/QTc interval as measured by the ECG, and to correlate QTcF interval with plasma total and ultrafilterable platinum concentrations. This study is also being conducted to ensure the safety of picoplatin with regard to the QT/QTc interval. Patients who choose to participate in this study will also be given the opportunity to continue to receive picoplatin until limited by toxicity or disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: PicoplatinPicoplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Documented histological or cytological diagnosis of non-hematological malignancy.
- Subjects for whom, in the opinion of the investigator, treatment with single agent picoplatin is appropriate.
- 18 years of age or older.
- ECOG performance status 0-2.
- An acceptable screening ECG.
Key exclusion criteria (24 listed)
- Symptomatic or uncontrolled brain metastases.
- Use of conventional granulocyte growth factors within the preceding 10 days or pegfilgrastim within the past 21 days.
- Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example,
- Unresolved toxicities from prior treatments of > Grade 1 (other than alopecia).
- Clinically significant infection.
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 |
|---|---|---|
| PicoplatinIV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Single Arm |
Primary outcome
ECG interval change
Time frame: 24 hours
1 secondary outcome
Safety/Efficacy
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
- Sponsors websiteLink provided by the sponsor.
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
Robert Earhart, MD, PhD study director
Poniard Pharmaceuticals
7 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 Picoplatin in people with Solid Tumors, run by Poniard Pharmaceuticals at 7 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 17 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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.
What does the primary outcome measure?
ECG interval change (time frame: 24 hours). 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 24 Sep 2009.