Solid TumorsPhase 1NCT00404521
A Phase I Study of PM02734 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study testing PM02734 in people with Solid Tumors, run by PharmaMar at 1 site in United States.
Trial summary
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced… 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?
- PM02734
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 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
- Voluntary written informed consent of the subject obtained before any study-specific procedure.
- Histologically or cytologically confirmed malignant solid tumor.
- Subjects with malignancies for which no standard therapy would reasonably be expected to result in cure or palliation.
- Age ≥ 18 years.
- Subject with measurable or non-measurable disease using the RECIST criteria (only subjects with measurable disease are allowed to enter the expanded cohort).
- Recovery from any drug-related adverse event derived from previous treatment, excluding alopecia and NCI-CTCAE grade 1 symptomatic peripheral neuropathy.
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- Laboratory values within 7 days prior to first infusion:
- Platelet count ≥ 100 x109/L , hemoglobin > 9 g/dL and absolute neutrophil count (ANC) ≥ 1.5 x109/L.
- Alkaline phosphatase ≤ 2.5 x the upper limit of normality (ULN) (< 5 x ULN in case of extensive bone metastases).
- Aspartate aminotransferase (AST): ≤ 2.5 x ULN (<5 x ULN in case of extensive liver metastases).
- Alanine aminotransferase (ALT): ≤ 2.5 x ULN (<5 x ULN in case of extensive liver metastases).
- Total bilirubin:1.5 ≤ ULN, unless due to Gilbert's syndrome.
- Creatinine: ≤ ULN, or measured creatinine clearance: ≥ 60 mL/min without significant proteinuria (>250 mg/m2 /day)
- Albumin ≥ 2.5 g/dL.
- Partial thromboplastin time ≤ 1.1 x ULN
- INR ≤ 1.1
- Performance status (ECOG) ≤ 2 .
- Life expectancy ≥ 3 months.
- Left ventricular ejection fraction (LVEF) within normal limits.
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include complete abstinence, IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
Who cannot join
- Prior therapy with PM02734.
- Pregnant or lactating women.
- Less than 4 weeks from radiation therapy (8 weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (6 weeks in case of nitrosourea, mitomycin C, or high-dose chemotherapy).
- Evidence of progressive CNS metastases or any symptomatic brain or leptomeningeal metastases.
- Evidence of extensive liver metastases ( more than 5 hepatic nodules and some of them greater than 5 cm in diameter)
- Other relevant diseases or adverse clinical conditions:
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- Increased cardiac risk: congestive heart failure or unstable angor pectoris or arrhythmia requiring treatment or uncontrolled arterial hypertension or myocardial infarction within 12 months before inclusion in the study.
- History of significant neurological or psychiatric disorders.
- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
- Significant non-neoplastic renal disease.
- Immunocompromised subjects, including subjects known to be infected by human immunodeficiency virus (HIV).
- Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder) (i.e. requiring relevant changes in medication within the last month or hospital admission within the last 3 months).
- Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
- Limitation of the subject's ability to comply with the treatment or to follow-up at a participating protocol. Subjects registered on this trial must be treated and followed at a participating center.
- Treatment with ongoing anti-coagulation.
- Treatment with any investigational product in the 30 days period prior to the first infusion.
- Known hypersensitivity to any of the components of the drug product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Center. University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: A Phase I Single-institution, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors.
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors.
Read the detailed description
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors. Secondary objectives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodynamics correlation and to evaluate the preliminary antitumor activity of PM02734. The trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
- Conditions
- Solid Tumors
- Being tested
- PM02734
- Keywords
- Tumor, PM02734, PharmaMar
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM02734Drug
Administered every 3 weeks, intravenously, over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: PM02734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734
Measured: Along the study
Secondary outcomes (1)
To determine preliminary pharmacokinetics, to explore relationships between pharmacokinetics/pharmacodynamics correlation and to evaluate preliminary antitumor activity of PM02734
Measured: Along the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startAug 2005
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Low rate recruitment
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Ratain, MD, Principal investigator, Cancer Research Centerr, University of Chicago Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404521
- Sponsor's protocol ID
- PM2734-A-001-05
- Status last verified
- Mar 2014
- First submitted
- 27 Nov 2006
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single-institution, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors.
- ClinicalTrials.gov ID
- NCT00404521
- Acronym / sponsor ID
- PM2734-A-001-05
- Conditions
- Solid Tumors
- Keywords
- Tumor, PM02734, PharmaMar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate recruitment
- Enrolment
- 56 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Nov 2006 (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.
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors.
Detailed description
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors. Secondary objectives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodynamics correlation and to evaluate the preliminary antitumor activity of PM02734. The trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PM02734 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntary written informed consent of the subject obtained before any study-specific procedure.
- Histologically or cytologically confirmed malignant solid tumor.
- Subjects with malignancies for which no standard therapy would reasonably be expected to result in cure or palliation.
- Age ≥ 18 years.
- Subject with measurable or non-measurable disease using the RECIST criteria (only subjects with measurable disease are allowed to enter the expanded cohort).
Key exclusion criteria (18 listed)
- Prior therapy with PM02734.
- Pregnant or lactating women.
- Less than 4 weeks from radiation therapy (8 weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (6 weeks in case of nitrosourea, mitomycin C, or high-dose chemotherapy).
- Evidence of progressive CNS metastases or any symptomatic brain or leptomeningeal metastases.
- Evidence of extensive liver metastases ( more than 5 hepatic nodules and some of them greater than 5 cm in diameter)
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 |
|---|---|---|
| PM02734Administered every 3 weeks, intravenously, over 30 minutes | Drug | Arm 1 |
Primary outcome
To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734
Time frame: Along the study
1 secondary outcome
To determine preliminary pharmacokinetics, to explore relationships between pharmacokinetics/pharmacodynamics correlation and to evaluate preliminary antitumor activity of PM02734
Time frame: Along the study
Results and safety
The study was stopped early (reason given: Low rate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Mark Ratain, MD principal investigator
Cancer Research Centerr, University of Chicago Hospital
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 PM02734 in people with Solid Tumors, run by PharmaMar 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 20 inclusion and 18 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 26 Mar 2014. 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 was stopped early (reason given: Low rate recruitment). 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?
To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734 (time frame: Along the study). 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 26 Mar 2014.