ADVANCED SOLID TUMORSPhase 1NCT00877474
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
A Phase 1 study testing PM01183 in people with ADVANCED SOLID TUMORS, run by PharmaMar at 2 sites in 2 countries.
Trial summary
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADVANCED SOLID TUMORS
- What is being tested?
- PM01183
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Jun 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 patient obtained before any study-specific procedure.
- Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist (excluding primary central nervous system tumors).
- Age ≥ 18 years.
- Patients with measurable or non-measurable disease according to RECIST.
- Patients entered at the expansion cohort of the RD must have:
- Measurable disease according to RECIST and/or, evaluable disease by serum markers in the case of prostate and ovarian cancer [according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively].
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- Confirmed progressive disease after last therapy, before study initiation.
- Available tumor samples (if pharmacogenomic study consented).
- Recovery from any drug-related adverse event derived from any previous treatment, excluding alopecia and grade ≤ 1 asymptomatic peripheral neuropathy according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0.
- Laboratory values within seven days prior to first infusion:
- Platelet count ≥ 100 x109/l, hemoglobin > 9 g/dl (patients can be transfused as clinically indicated prior to study entry) and absolute neutrophils count (ANC) ≥ 1.5 x109/l.
- Alkaline phosphatase ≤ 2.5 x the upper limit of normality (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN.
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- Total bilirubin ≤ ULN. f) Calculated creatinine clearance: ≥ 40 ml/min (calculated using the Cockcroft and Gault formula).
- Albumin ≥ 2.5 g/dl.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- 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 6 months after discontinuation of treatment. Acceptable methods of contraception include: intrauterine conceptive device (IUD), oral contraceptives, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
Who cannot join
- Pregnant or lactating women.
- Less than three weeks from radiation therapy (six weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (six weeks in case of nitrosoureas, mitomycin C, trastuzumab, bicalutamide or high-dose chemotherapy).
- Evidence of progressive Central Nervous System (CNS) metastases or any symptomatic brain or leptomeningeal metastases.
- Patients for whom non-standard surgery approach may result in tumor free survival or significant palliation.
- Other relevant diseases or adverse clinical conditions:
- Increased cardiac risk: symptomatic and/or medication requiring congestive heart failure or clinically relevant valvular heart disease or unstable angor pectoris or myocardial infarction within 12 months before inclusion in the study, or ≥ grade 1 arrhythmia or any grade requiring treatment, or uncontrolled arterial hypertension (≥ 160/100 mmHg) despite optimal medical therapy.
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- History of significant neurological or psychiatric disorders.
- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
- Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).
- Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
- Limitation of the patient's ability to comply with the treatment or to follow-up at a participating protocol. Patients registered on this trial must be treated and followed at a participating center.
- Prior treatment with any investigational product in the period ≥ 5 half-lives of the investigational compound prior to the first infusion.
- Known hypersensitivity to any of the components of the drug product.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Cancer Research Center. University of Chicago Hospitals.
Chicago, Illinois, 60637
About this study
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
Read the detailed description
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors to identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors and to preliminarily determine the pharmacokinetics of PM01183, to evaluate the antitumor activity of PM01183 and the safety and tolerability of PM01183. Besides this study will evaluate the pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) of patients exposed to PM01183 at the RD in order to assess potential markers of response and/or resistance.
- Conditions
- ADVANCED SOLID TUMORS
- Being tested
- PM01183
- Keywords
- PM01183, Solid tumors, PharmaMar USA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM01183Drug
Vials containing 0.2 mg of PM01183 as powder for concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | PM01183 administered i.v. over one hour, on Day 1, every three weeks, at a starting dose of 20 µg/m2. Receives: Drug: PM01183 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors.
Measured: Along the study
Secondary outcomes (1)
To preliminarily determine: pharmacokinetics, antitumor activity and safety of PM01183 and to determine pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) at the RD
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 posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADVANCED 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
- 30 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 Center. University of Chicago Hospitals.Josep Tabernero, MD, Principal investigator, Vall d'Hebron University Hospital. Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877474
- Sponsor's protocol ID
- PM1183-A-001-08
- Status last verified
- Nov 2015
- First submitted
- 6 Apr 2009
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.
PubMed 33914350Elez ME, Tabernero J, Geary D, Macarulla T, Kang SP, Kahatt C, Pita AS, Teruel CF, Siguero M, Cullell-Young M, Szyldergemajn S, Ratain MJ. First-in-human phase I study of Lurbinectedin (PM01183) in patients with advanced solid tumors. Clin Cancer Res. 2014 Apr 15;20(8):2205-14. doi: 10.1158/1078-0432.CCR-13-1880. Epub 2014 Feb 21.
PubMed 24563480
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00877474
- Acronym / sponsor ID
- PM1183-A-001-08
- Conditions
- ADVANCED SOLID TUMORS
- Keywords
- PM01183, Solid tumors, PharmaMar USA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Apr 2009 (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 phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
Detailed description
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors to identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors and to preliminarily determine the pharmacokinetics of PM01183, to evaluate the antitumor activity of PM01183 and the safety and tolerability of PM01183. Besides this study will evaluate the pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) of patients exposed to PM01183 at the RD in order to assess potential markers of response and/or resistance.
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: PM01183PM01183 administered i.v. over one hour, on Day 1, every three weeks, at a starting dose of 20 µg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntary written informed consent of the patient obtained before any study-specific procedure.
- Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist (excluding primary central nervous system tumors).
- Age ≥ 18 years.
- Patients with measurable or non-measurable disease according to RECIST.
- Patients entered at the expansion cohort of the RD must have:
Key exclusion criteria (14 listed)
- Pregnant or lactating women.
- Less than three weeks from radiation therapy (six weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (six weeks in case of nitrosoureas, mitomycin C, trastuzumab, bicalutamide or high-dose chemotherapy).
- Evidence of progressive Central Nervous System (CNS) metastases or any symptomatic brain or leptomeningeal metastases.
- Patients for whom non-standard surgery approach may result in tumor free survival or significant palliation.
- Other relevant diseases or adverse clinical conditions:
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 |
|---|---|---|
| PM01183Vials containing 0.2 mg of PM01183 as powder for concentrate for solution for infusion | Drug | Arm 1 |
Primary outcome
To identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors.
Time frame: Along the study
1 secondary outcome
To preliminarily determine: pharmacokinetics, antitumor activity and safety of PM01183 and to determine pharmacogenomics in tumor samples and peripheral white blood cells (PWBCs) at the RD
Time frame: Along the study
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 4 Nov 2015.
- Derived from this study: PubMed 33914350Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.
- Derived from this study: PubMed 24563480Elez ME, Tabernero J, Geary D, Macarulla T, Kang SP, Kahatt C, Pita AS, Teruel CF, Siguero M, Cullell-Young M, Szyldergemajn S, Ratain MJ. First-in-human phase I study of Lurbinectedin (PM01183) in patients with advanced solid tumors. Clin Cancer Res. 2014 Apr 15;20(8):2205-14. doi: 10.1158/1078-0432.CCR-13-1880. Epub 2014 Feb 21.
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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 Center. University of Chicago Hospitals.
Josep Tabernero, MD principal investigator
Vall d'Hebron University Hospital. Barcelona (Spain)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PM01183 in people with ADVANCED SOLID TUMORS, run by PharmaMar at 2 sites in 2 countries.
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 18 inclusion and 14 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 4 Nov 2015. 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, Spain. 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 identify the dose limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered every three weeks intravenously (i.v.) over one hour to patients with advanced solid tumors. (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?
On the ClinicalTrials.gov record for NCT00877474, which also lists 2 linked publications.
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 4 Nov 2015.