Breast CancerPhase 1NCT01831089

Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors

A Phase 1 study testing PM01183 + paclitaxel +/- bevacizumab in people with Breast Cancer and Ovarian Cancer, run by PharmaMar at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Breast Cancer, Ovarian Cancer, Gynecological Cancer
What is being tested?: PM01183 + paclitaxel +/- bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 3 sitesin 3 countries
Study dates: Sep 2013to Jul 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily signed and dated written informed consent
Age between 18 and 75 years old (both inclusive)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1
Life expectancy ≥ 3 months.
Patients with a histologically/cytologically confirmed diagnosis of advanced and/or unresectable disease of any of the following tumors:
Breast cancer

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Epithelial ovarian cancer or gynecological cancer
Head and neck squamous cell carcinoma
Non-small cell lung cancer
Small cell lung cancer
Platinum-refractory germ-cell tumors.
Adenocarcinoma or carcinoma of unknown primary site
Adequate bone marrow, renal, hepatic, and metabolic function
Recovery to grade ≤ 1 or to baseline from any Adverse Event (AE) derived from previous treatment (excluding alopecia of any grade).
Pre-menopausal women must have a negative pregnancy test before study entry and agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation

Who cannot join

Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel
Patients who have previously discontinued paclitaxel-based regimes due to drug related toxicity.
Known hypersensitivity to bevacizumab or any component of its formulation
Patients who have previously discontinued bevacizumab-containing regimes due to drug-related toxicity.
More than three prior lines of chemotherapy
Less than three months since last taxane-containing therapy.

Show all 16Show fewer

Wash-out period:
Less than three weeks since the last chemotherapy-containing regimen
Less than three weeks since the last radiotherapy dose
Less than four weeks since last monoclonal antibody-containing therapy
Concomitant diseases/conditions:
Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems, peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal disease.
Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women.
Patients who have pelvic irradiation with doses ≥ 45 Grays (Gy).
History of previous bone marrow and/or stem cell transplantation.
Confirmed bone marrow involvement

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Study site
New York, New York

Other trials in United States

Spain1 site

Study site
Madrid

Other trials in Spain

Switzerland1 site

Study site
Bellinzona

Other trials in Switzerland

About this study

Official title: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors

Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors

Read the detailed description

Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK(pharmacokinetic)/PD(pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.

Conditions: Breast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer
Being tested: PM01183 + paclitaxel +/- bevacizumab
Medical subject headings: Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PM01183 + paclitaxel +/- bevacizumabDrug
PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion
paclitaxel: 6 mg/ml concentrate for solution for infusion
bevacizumab: 25 mg/ml concentrate for solution for infusion
Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients

Study groups in NCT01831089
Study group	Role	What they receive
Treatment	Experimental	PM01183 + paclitaxel +/- bevacizumab Receives: Drug: PM01183 + paclitaxel +/- bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD)
The MTD will be the lowest level at which one third or more evaluable patients experience a DLT in Cycle 1.
DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.
Measured: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)
Recommended Dose (RD)
The RD will be the highest DL explored with less than one third of the patients experiencing a DLT during Cycle 1.
DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.
Measured: The RD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.
Measured: DLT was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)

Secondary outcomes (4)

Best Tumor Response
Best overall response:Best response recorded from the start of the study treatment until the end of treatment Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10 mm Partial Response (PR):At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression) Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF):symptomatic deterioration or death due to progression
Measured: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Progression-free Survival
Progression-free survival (PFS) was defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death had not occurred at the time of the analysis, the PFS was censored.
Measured: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Duration of Response (DR)
Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented
Measured: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Quality of Life (QoL)
Change from baseline to last cycle. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL scale scores.
The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC QLQ-C30 (version 3.0) developed for palliative care. Wilcoxon signed ranks test repeat-measure analyses of variance were used to measure the change value from baseline value. Data has to be analysed following the corresponding EORTC manual http://www.eortc.be/qol/files/SCManualQLQ-C15-PAL.pdf and the overall quality of life assessment is contained in 0 to 100 where a higher value represents a better state.
Measured: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jul 2016

First posted15 Apr 2013 (estimated)
Study startSep 2013
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01831089
Sponsor's protocol ID: PM1183-A-007-13
Status last verified: Mar 2020
First submitted: 2 Apr 2013
Last updated: 10 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2020. 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 Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01831089
Acronym / sponsor ID: PM1183-A-007-13
Conditions: Breast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: PharmaMarIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 15 Apr 2013 (estimated)
Results: Posted 20 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: PM01183 + paclitaxel +/- bevacizumabPM01183 + paclitaxel +/- bevacizumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Voluntarily signed and dated written informed consent
Age between 18 and 75 years old (both inclusive)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1
Life expectancy ≥ 3 months.
Patients with a histologically/cytologically confirmed diagnosis of advanced and/or unresectable disease of any of the following tumors:

Key exclusion criteria (16 listed)

Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel
Patients who have previously discontinued paclitaxel-based regimes due to drug related toxicity.
Known hypersensitivity to bevacizumab or any component of its formulation
Patients who have previously discontinued bevacizumab-containing regimes due to drug-related toxicity.
More than three prior lines of chemotherapy

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
PM01183 + paclitaxel +/- bevacizumabPM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion paclitaxel: 6 mg/ml concentrate for solution for infusion bevacizumab: 25 mg/ml concentrate for solution for infusion Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients	Drug	Treatment

Primary outcome

Maximum Tolerated Dose (MTD)
Time frame: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)
The MTD will be the lowest level at which one third or more evaluable patients experience a DLT in Cycle 1. DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.
Recommended Dose (RD)
Time frame: The RD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)
The RD will be the highest DL explored with less than one third of the patients experiencing a DLT during Cycle 1. DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: DLT was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)
DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.

4 secondary outcomes

Best Tumor Response
Time frame: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Progression-free Survival
Time frame: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Duration of Response (DR)
Time frame: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)
Quality of Life (QoL)
Time frame: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]	3	0
Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]	0	0
Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD	0	0
Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]	0	0
Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]	0	0
Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg	0	0

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks). Number. Unit: mg/m2 / mg FD

Measure	Group A (Paclitaxel/PM01183) n = 52
Value	NA

Population analysed: Three patients at the RD were not evaluable because they did not receive a complete Cycle 1 due to disease-related grade 3 vomiting and early PD, disease-related grade 3 confusional state, and because not enough information for DLT evaluation was collected during Cycle 1.

Primary outcome: Recommended Dose (RD)

Time frame: The RD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks). Number. Unit: mg/m2 / mg FD

Measure	Group A (Paclitaxel/PM01183) n = 52
Value	NA

Primary outcome: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Time frame: DLT was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks). Count of participants. Unit: Participants

Measure	Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD] n = 3	Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD] n = 3	Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD n = 6	Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD] n = 6	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] n = 34	Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg n = 12
Value	0	0	2	3	6	3

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel [60.0 mg/m2] / PM01183 [3.0 mg FD]	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Paclitaxel [60.0 mg/m2] / PM01183 [4.0 mg FD]	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Paclitaxel 60.0 mg/m2 / PM01183 5.0 mg FD	3 of 6 (50%)	6 of 6 (100%)	0 of 6
Paclitaxel [80.0 mg/m2] / PM01183 [5.0 mg FD]	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD]	15 of 37 (40.5%)	36 of 37 (97.3%)	3 of 37
Paclitaxel [80.0 mg/m2] / PM01183 [4.0 mg FD] / BEV 15 mg/kg	7 of 14 (50%)	12 of 14 (85.7%)	2 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PM01183 + paclitaxel +/- bevacizumab in people with Breast Cancer and Ovarian Cancer, run by PharmaMar at 3 sites in 3 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 15 inclusion and 16 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 10 Apr 2020. 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, Spain, 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?

Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) (time frame: The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)). The study lists 3 primary outcomes in all. 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 NCT01831089.

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 10 Apr 2020.