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Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lurbinectedin (PM01183) | Experimental | lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lurbinectedin (PM01183) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
| Response by Investigator Assessment | When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials. | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented. | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
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Inclusion Criteria:
Age ≥ 18 years.
Voluntary signed informed consent (IC)
Pathologically proven diagnosis of any of the following malignancies:
Prior treatment. Patients must have received:
Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
Adequate major organ function
At least three weeks since the last chemotherapy
Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Research Center, LLC | Santa Monica | California | 90403 | United States | ||
| University of Colorado Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37556023 | Derived | Kristeleit R, Leary A, Delord JP, Moreno V, Oaknin A, Castellano D, Shappiro GI, Fernandez C, Kahatt C, Alfaro V, Siguero M, Rueda D, Zeaiter A, Awada A, Santaballa A, Zaman K, Sehouli J, Subbiah V. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study. Invest New Drugs. 2023 Oct;41(5):677-687. doi: 10.1007/s10637-023-01383-2. Epub 2023 Aug 9. | |
| 36037567 |
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The first patient registration was on 25 August 2015 and the first study treatment administration was on 25 August 2015. The last patient registration was on 30 November 2018 and the last study treatment administration was on 29 November 2019. The date of last follow-up (cutoff-date) was 18 September 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biliary Tract Carcinoma Cohort | Patients with Pathologically proven diagnosis of biliary tract carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2020 | Feb 1, 2023 |
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| Clinical Benefit | Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months) | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
| Disease Control Rate | Disease Control Rate was defined as Overall Response Rate or Stable Disease | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 |
| Progression Free Survival (PFS) | Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years |
| Progression-free Survival at 4 Months | Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | At 4 months |
| Progression-free Survival at 6 Months | Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | At 6 months |
| Overall Survival (OS) | Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort. | From the date of first infusion to the date of death or last contact, up to an average of 5 years |
| Overall Survival at 6 Months | Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months | At 6 months |
| Overall Survival at 12 Months | Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months | At 12 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Massachussets General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Centre | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Hôpital Cochin | Paris | 75014 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Charité Universitätsmedizin Berlin - Campus Benjamin Franklin - Comprehensive Cancer Center | Berlin | 12200 | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Istituto Clinico Humanitas | Rozzano | Milan | 20089 | Italy |
| Istituto Ortopedico Rizzoli | Bologna | Italy |
| lstituto Europeo di Oncologia | Milan | 20141 | Italy |
| ASST Monza - Ospedale San Gerardo di Monza Struttura Complessa di Oncologia Medica | Monza | 20090 | Italy |
| AUSL Romagna - Ospedale Santa Maria delle Croci | Ravenna | 48121 | Italy |
| Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hopsital Universitario Donostia - Donostia Unibertsitate Ospitalea | San Sebastián | Guipúzcoa | 20014 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Complejo Hospitalario De Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitari Vall D' Hebron | Barcelona | 08035 | Spain |
| Complejo Hospitalario Regional Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Complejo Hospitalario de Especialidades Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitari i Polotècnic la Fe | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Skane University Hospital | Lund | 22185 | Sweden |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
| Istituto Oncologico della Svizzera Italiana (IOSI) | Bellinzona | 6500 | Switzerland |
| UCL Cancer Institute | London | WC1E 6DD | United Kingdom |
| Derived |
| Boni V, Pistilli B, Brana I, Shapiro GI, Trigo J, Moreno V, Castellano D, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Longo F, Zaman K, Anton A, Paredes A, Huidobro G, Subbiah V. Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study. ESMO Open. 2022 Oct;7(5):100571. doi: 10.1016/j.esmoop.2022.100571. Epub 2022 Aug 28. |
| 35830841 | Derived | Longo-Munoz F, Castellano D, Alexandre J, Chawla SP, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garcia E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10. |
| 35486638 | Derived | Subbiah V, Brana I, Longhi A, Boni V, Delord JP, Awada A, Boudou-Rouquette P, Sarantopoulos J, Shapiro GI, Elias A, Ratan R, Fernandez C, Kahatt C, Cullell-Young M, Siguero M, Zeaiter A, Chawla SP. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study. Clin Cancer Res. 2022 Jul 1;28(13):2762-2770. doi: 10.1158/1078-0432.CCR-22-0696. |
| 34739582 | Derived | Fernandez-Teruel C, Fudio S, Lubomirov R. Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer. Cancer Chemother Pharmacol. 2022 May;89(5):585-594. doi: 10.1007/s00280-021-04366-3. Epub 2021 Nov 5. |
| 33096421 | Derived | Subbiah V, Paz-Ares L, Besse B, Moreno V, Peters S, Sala MA, Lopez-Vilarino JA, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Zaman K, Lopez R, Ponce S, Boni V, Arrondeau J, Delord JP, Martinez M, Wannesson L, Anton A, Valdivia J, Awada A, Kristeleit R, Olmedo ME, Rubio MJ, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D' Arcangelo M, Santoro A, Villalobos VM, Sands J, Trigo J. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment. Lung Cancer. 2020 Dec;150:90-96. doi: 10.1016/j.lungcan.2020.10.003. Epub 2020 Oct 10. |
| 32224306 | Derived | Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. |
| FG001 | Carcinoma of Unknown Primary Site Cohort | Patients with pathologically proven diagnosis of carcinoma of unknown primary site Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG002 | Endometrial Carcinoma Cohort | Patients with pathologically proven diagnosis of endometrial carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG003 | Ewing's Family of Tumors Cohort | Patients with pathologically proven diagnosis of Ewing's Family of Tumors Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| FG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m^2. Dose was capped at body surface area (BSA) of 2.0 m^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Treated patients only
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| ID | Title | Description |
|---|---|---|
| BG000 | Biliary Tract Carcinoma Cohort | Patients with Pathologically proven diagnosis of biliary tract carcinoma |
| BG001 | Carcinoma of Unknown Primary Site Cohort | Patients with pathologically proven diagnosis of carcinoma of unknown primary site |
| BG002 | Endometrial Carcinoma Cohort | Patients with pathologically proven diagnosis of endometrial carcinoma |
| BG003 | Ewing's Family of Tumors Cohort | Patients with pathologically proven diagnosis of Ewing's Family of Tumors |
| BG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| BG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| BG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| BG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| BG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
| BG009 | 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group performance status | Eastern Cooperative Oncology Group performance status 0 Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
| |||||||||||||||
| Weight | Median | Full Range | kg |
| |||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||
| Body surface area | Median | Full Range | m^2 |
| |||||||||||||||
| Albumin | Median | Full Range | g/dL |
| |||||||||||||||
| Albumin | Count of Participants | Participants |
| ||||||||||||||||
| Stage at diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Number of sites at baseline | Median | Full Range | sites at baseline |
| |||||||||||||||
| Sites at baseline | Count of Participants | Participants |
| ||||||||||||||||
| Time from diagnosis to registration | Median | Full Range | months |
| |||||||||||||||
| Time from advanced disease to registration | Median | Full Range | month |
| |||||||||||||||
| Prior surgery | Count of Participants | Participants |
| ||||||||||||||||
| Prior radiotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Systemic lines | Count of Participants | Participants |
| ||||||||||||||||
| Advanced chemotherapy lines | Count of Participants | Participants |
| ||||||||||||||||
| Best response to last therapy | According to the RECIST v.1.1, Complete Response: Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease (PD): ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD | Count of Participants | Participants |
| |||||||||||||||
| Time to progression to last prior therapy | Median | Full Range | months |
| |||||||||||||||
| Time from last progression disease before study entry | Median | Full Range | weeks |
|
| 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 | Overall Response Rate (ORR) | Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD | Treated patients and with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
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| Primary | Response by Investigator Assessment | When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials. | Treated patients with disease measurement | Posted | Count of Participants | Participants | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
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| Secondary | Duration of Response | Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented. | Patients with response to treatment | Posted | Median | 95% Confidence Interval | months | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
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| Secondary | Clinical Benefit | Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months) | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) |
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| Secondary | Disease Control Rate | Disease Control Rate was defined as Overall Response Rate or Stable Disease | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of paticipants | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 |
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| Secondary | Progression Free Survival (PFS) | Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | Treated patients with disease measurement | Posted | Median | 95% Confidence Interval | months | From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years |
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| Secondary | Progression-free Survival at 4 Months | Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | At 4 months |
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| Secondary | Progression-free Survival at 6 Months | Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort. | Treated patients with disease measurement | Posted | Median | 95% Confidence Interval | months | From the date of first infusion to the date of death or last contact, up to an average of 5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 6 Months | Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 12 Months | Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months | Treated patients with disease measurement | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
|
From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population.
Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
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 | Lurbinectedin (PM01183) | Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle). | 261 | 335 | 136 | 335 | 330 | 335 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Subacute combined cord degeneration | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA (21.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cementoplasty | Surgical and medical procedures | MedDRA (21.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-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 more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development, Department of PharmaMar´s Oncology., Business Unit. | Pharma Mar S.A. | 0034 91846 60 00 | clinicaltrials@pharmamar.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2020 | Sep 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C568606 | PM 01183 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black of African American |
|
| Asian |
|
| American Indian or Alaska native |
|
| Not race available |
|
| Belgium |
|
| United States |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Switzerland |
|
| Germany |
|
| Spain |
|
| 1 |
|
| 2 |
|
| ≥3.5 g/dL |
|
| Locally advanced |
|
| Metastatic |
|
| ≥3 sites |
|
| 2 lines |
|
| 3 lines |
|
| 4 or more lines |
|
| 1 line |
|
| 2 lines |
|
| 3 lines |
|
| 4 or more lines |
|
| Partial reponse |
|
| Stable disease |
|
| Progression disease |
|
| Unknown |
|
| OG002 | Endometrial Carcinoma Cohort | Patients with pathologically proven diagnosis of endometrial carcinoma |
| OG003 | Ewing's Family of Tumors Cohort | Patients with pathologically proven diagnosis of Ewing's Family of Tumors |
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| Germ Cell Tumors Cohort |
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
| OG004 | Germ Cell Tumors Cohort | Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. |
| OG005 | Head and Neck Carcinoma Cohort | Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. |
| OG006 | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma |
| OG007 | Neuroendocrine Tumors Cohort | Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. |
| OG008 | Small Cell Lung Cancer Cohort | Patients with pathologically proven diagnosis of small cell lung cancer |
|
|