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A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients
A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - docetaxel | Active Comparator | 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks |
|
| B - lurbinectedin (PM01183) | Experimental | 3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks |
|
| C - gemcitabine + lurbinectedin (PM01183) | Experimental | 800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Powder for solution for infusion |
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate at Four Months (PFS4) | The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | At month four after patient inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | United States |
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69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Docetaxel | 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks Docetaxel: Powder for solution for infusion |
| FG001 | B - Lurbinectedin (PM01183) | In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Powder for solution for infusion |
|
| Lurbinectedin (PM01183) | Drug | Powder for concentrate for solution for infusion |
|
| Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
| Progression-free Survival Rate at Six Months (PFS6) | The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | At month six after patient inclusion |
| Overall Response Rate | Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1. 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. | Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years |
| Objective Response Per RECIST v.1.1 | RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10mm 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 5mm. Appearance of new lesions was considered PD 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/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed | Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years |
| Duration of Response | 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. 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. | 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, up to 3 years |
| Overall Survival (OS) | Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact | From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion |
| Information on Quality of Life (QoL) | The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy. Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient Ãtems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL) | Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks) |
| FG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
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| NOT COMPLETED |
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|
69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Docetaxel | 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks Docetaxel: Powder for solution for infusion |
| BG001 | B - Lurbinectedin (PM01183) | In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
| BG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| ECOG PS | ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active, able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours PS 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours PS 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead | Count of Participants | Participants |
| |||||||||||||||
| Histology type | Count of Participants | Participants |
| ||||||||||||||||
| Histology grade | Count of Participants | Participants |
| ||||||||||||||||
| Stage at diagnosis | Count of Participants | Participants |
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| Stage at study entry | Count of Participants | Participants |
| ||||||||||||||||
| Surgery | Count of Participants | Participants |
| ||||||||||||||||
| Radiotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Prior chemotherapy | Number of prior lines | Count of Participants | Participants |
| |||||||||||||||
| Best response to last prior platinum | Best response to last prior platinum based chemotherapy NA, not applicable; PD, progressive disease; PR, partial response; SD, stable disease; UK, unknown | Count of Participants | Participants |
| |||||||||||||||
| Weight | Median | Full Range | Kg |
| |||||||||||||||
| Body Surface Area | Median | Full Range | m^2 |
| |||||||||||||||
| Signs and symptoms per patient | Prior history per patient by MedDRA category, eg., cough, dyspnea, fatigue... | Median | Full Range | Signs and symptoms |
| ||||||||||||||
| Albumin | Median | Full Range | g/dL |
| |||||||||||||||
| Alpha-1-acid glycoprotein | Median | Full Range | mg/dL |
| |||||||||||||||
| Time from first diagnosis to first infusion | Median | Full Range | months |
| |||||||||||||||
| Number of sites involved at baseline | Median | Full Range | sites |
| |||||||||||||||
| Platinum-free interval | Median | Full Range | months |
| |||||||||||||||
| PFS to last prior line | PFS, progression-free survival Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression | Median | Full Range | mohths |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival Rate at Four Months (PFS4) | The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment | Posted | Number | 95% Confidence Interval | percentage of participants | At month four after patient inclusion |
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| Secondary | Progression-free Survival | PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
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| Secondary | Progression-free Survival Rate at Six Months (PFS6) | The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment | Posted | Number | 95% Confidence Interval | percentage of participants | At month six after patient inclusion |
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| Secondary | Overall Response Rate | Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1. 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. | B - 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years |
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| Secondary | Objective Response Per RECIST v.1.1 | RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10mm 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 5mm. Appearance of new lesions was considered PD 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/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed | B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C- 2 no tumour assesment | Posted | Count of Participants | Participants | Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years |
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| Secondary | Duration of Response | 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. 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. | Two patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm A. No patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm B. Four patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm C. | Posted | Median | 95% Confidence Interval | months | 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, up to 3 years |
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| Secondary | Overall Survival (OS) | Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact | Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment | Posted | Median | 95% Confidence Interval | months | From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion |
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| Secondary | Information on Quality of Life (QoL) | The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy. Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient Ãtems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL) | No patients in cycle 9 in arm A and arm C. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks) |
|
Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A - Docetaxel | 75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks Docetaxel: Powder for solution for infusion | 14 | 22 | 12 | 22 | 21 | 22 |
| EG001 | B - Lurbinectedin (PM01183) | In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles Lurbinectedin (PM01183): Powder for concentrate for solution for infusion | 17 | 21 | 9 | 21 | 20 | 21 |
| EG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion | 21 | 25 | 18 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia/Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia/Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharma Mar S.A. | Pharma Mar S.A. | 00 34 91846 60 00 | clinicaltrials@pharmamar.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| C568606 | PM 01183 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Unknown |
|
| Italy |
|
| Belgium |
|
| Spain |
|
| PS 1 |
|
| Squamous-cell |
|
| Not specified |
|
| Moderately differentiated |
|
| Poorly differentiated |
|
| Unknown |
|
| Locally advanced |
|
| Metastatic |
|
| Unknown |
|
| Metastatic |
|
| No |
|
| No |
|
| 2 lines |
|
| SD |
|
| PD |
|
| NA |
|
| UK |
|
| The exact binomial estimator |
| 19.0 |
| 2-Sided |
| 95 |
| 5.7 |
| 37.9 |
| Superiority |
| The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed | The exact binomial estimator | 28.0 | 2-Sided | 95 | 12.6 | 46.7 | Superiority |
| OG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
|
|
|
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
|
|
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
|
|
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
| OG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
|
|
| OG002 | C - Gemcitabine + Lurbinectedin (PM01183) | Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3) Gemcitabine: Powder for solution for infusion Lurbinectedin (PM01183): Powder for concentrate for solution for infusion |
|
|
|
|
|
|
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|
|