Advanced Solid TumorsPhase 1NCT01980667
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors
A Phase 1 study testing lurbinectedin (PM01183) and Cisplatin in people with Advanced Solid Tumors, run by PharmaMar at 3 sites in 2 countries.
Trial summary
Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary… 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?
- lurbinectedin (PM01183) and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Jul 2014to 5 Jan 2017
- 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
- Voluntarily signed written informed consent
- Age ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1.
- Life expectancy ≥ 3 months.
- Patients with confirmed diagnosis of advanced solid tumors.
- Patients may have received ≤ 2 chemotherapy-containing lines in the advanced setting.
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- Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ seven days before inclusion in the study)
- Recovery or stabilization to grade ≤ 1 from any adverse event derived from previous treatment (up to grade 2 alopecia or asthenia/fatigue are allowed).
- No clinically significant changes in ECG.
- At least four weeks since the last monoclonal antibody containing therapy or definitive radiotherapy (RT)
- At least two weeks since the last biological/investigational single-agent therapy (excluding MAbs) and/or palliative RT (≤10 fractions or ≤30 Gy total dose)
- Fertil women must have pregnancy excluded by appropriate testing before study entry
Who cannot join
- Prior treatment with PM01183 or trabectedin.
- Concomitant diseases/conditions:
- History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
- Ongoing, non-neoplastic, chronically active liver disease of any origin.
- Active infection.
- Patients who are requiring any ongoing oxygen support.
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- Known human immunodeficiency virus (HIV) infection.
- Any other major illness.
- Symptomatic or corticosteroid-requiring brain metastases or leptomeningeal disease involvement. Patients with asymptomatic documented stable brain metastases not requiring corticosteroids during the last three months are allowed.
- Peripheral sensory/motor neuropathy grade >1. Hearing impairment grade >1.
- Fertile men or women not using an effective method of contraception.
- History of bone marrow or stem cell transplantation
- Radiotherapye to >35% of the bone marrow.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors
Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.
- Conditions
- Advanced Solid Tumors
- Being tested
- lurbinectedin (PM01183), Cisplatin
- Keywords
- lurbinectedin, PM01183, tumors, cancer, Pharma Mar
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lurbinectedin (PM01183)Drug
lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
CisplatinDrug
vials containing 1 mg/ml concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| lurbinectedin (PM01183) / cisplatin | Experimental | Patients will receive cisplatin as a 90-min i.v. infusion. In addition, patients will receive PM01183 as an i.v. infusion over 1-hour. Receives: Drug: lurbinectedin (PM01183); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose (RD) of the combination PM01183 and cisplatin
To determine the recommended dose (RD) of PM01183 in combination with cisplatin every three weeks (q3wk) with or without aprepitant in patients with advanced solid tumors. The RD will be the dose level (DL) immediately below the maximum tolerated dose (MTD), that is, the highest DL explored at which less than one third of evaluable patients experience a DLT during Cycle 1.
Measured: 30 months
Secondary outcomes (2)
Pharmacokinetics (PK) characterisation of Cmax (maximum concentratio), AUC (area under the curve), CL (clearance), HL (half life) y Vss (volume of distribution)
To characterize the pharmacokinetics (PK) parameters Cmax (maximum concentratio), AUC (area under the curve), CL (clearance), HL (half life) y Vss (volume of distribution ) of this combination in patients receiving/not receiving aprepitant and to explore factors that may affect individual variability in main PK parameters.
Measured: 30 months
Pharmacogenomic (PGx) analysis
To conduct an exploratory pharmacogenomic (PGx) analysis to identify and validate putative molecular markers associated with the clinical outcome of patients treated with PM01183 and cisplatin. These molecular markers would help in the future selection of patients who might preferentially benefit from PM01183 therapy, thus contributing to improve health care through a more individualized medicine.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start30 Jul 2014
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980667
- Sponsor's protocol ID
- PM1183-A-008-13
- Status last verified
- Jan 2017
- First submitted
- 22 Oct 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Metaxas Y, Kahatt C, Alfaro V, Fudio S, Zeaiter A, Plummer R, Sessa C, Von Moos R, Forster M, Stathis A. A phase I trial of lurbinectedin in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2022 Feb;40(1):91-98. doi: 10.1007/s10637-021-01142-1. Epub 2021 Aug 28.
PubMed 34453241
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01980667
- Acronym / sponsor ID
- PM1183-A-008-13
- Conditions
- Advanced Solid Tumors
- Keywords
- lurbinectedin, PM01183, tumors, cancer, Pharma Mar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2014
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 11 Nov 2013 (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.
Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lurbinectedin (PM01183) / cisplatin | Experimental | Drug: lurbinectedin (PM01183), Drug: CisplatinPatients will receive cisplatin as a 90-min i.v. infusion. In addition, patients will receive PM01183 as an i.v. infusion over 1-hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily signed written informed consent
- Age ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1.
- Life expectancy ≥ 3 months.
- Patients with confirmed diagnosis of advanced solid tumors.
Key exclusion criteria (13 listed)
- Prior treatment with PM01183 or trabectedin.
- Concomitant diseases/conditions:
- Symptomatic or corticosteroid-requiring brain metastases or leptomeningeal disease involvement. Patients with asymptomatic documented stable brain metastases not requiring corticosteroids during the last three months are allowed.
- Peripheral sensory/motor neuropathy grade >1. Hearing impairment grade >1.
- Fertile men or women not using an effective method of contraception.
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 |
|---|---|---|
| lurbinectedin (PM01183)lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials. | Drug | lurbinectedin (PM01183) / cisplatin |
| Cisplatinvials containing 1 mg/ml concentrate for solution for infusion | Drug | lurbinectedin (PM01183) / cisplatin |
Primary outcome
Recommended dose (RD) of the combination PM01183 and cisplatin
Time frame: 30 months
To determine the recommended dose (RD) of PM01183 in combination with cisplatin every three weeks (q3wk) with or without aprepitant in patients with advanced solid tumors. The RD will be the dose level (DL) immediately below the maximum tolerated dose (MTD), that is, the highest DL explored at which less than one third of evaluable patients experience a DLT during Cycle 1.
2 secondary outcomes
Pharmacokinetics (PK) characterisation of Cmax (maximum concentratio), AUC (area under the curve), CL (clearance), HL (half life) y Vss (volume of distribution)
Time frame: 30 months
Pharmacogenomic (PGx) analysis
Time frame: 30 months
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 26 Jan 2017.
- Derived from this study: PubMed 34453241Metaxas Y, Kahatt C, Alfaro V, Fudio S, Zeaiter A, Plummer R, Sessa C, Von Moos R, Forster M, Stathis A. A phase I trial of lurbinectedin in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2022 Feb;40(1):91-98. doi: 10.1007/s10637-021-01142-1. Epub 2021 Aug 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 lurbinectedin (PM01183) and Cisplatin in people with Advanced Solid Tumors, run by PharmaMar at 3 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 12 inclusion and 13 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 26 Jan 2017. 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 Kingdom, Switzerland. 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?
Recommended dose (RD) of the combination PM01183 and cisplatin (time frame: 30 months). 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 NCT01980667, which also lists 1 linked publication.
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 Jan 2017.