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A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx) expression profile in tumor samples.
A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer to assess the antitumor activity of PM01183 in terms of overall response rate (ORR), duration of response (DR),clinical benefit [ORR or stable disease lasting over three months (SD > 3 months)], progression free survival (PFS), and one-year overall survival (1y-OS) and to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in MBC patients, to explore the activity of PM01183 in specific breast cancer subpopulations according to hormonal receptor status, HER-2 overexpression, number and/or type of prior therapies, or according to other available histological/molecular classifications, to evaluate the safety profile of this PM01183 administration schedule [Day 1 every three weeks (q3wk)] in this patient population, to analyze the pharmacokinetics (PK) of PM01183 in this patient population, to explore PK/PD (pharmacokinetic/ pharmacodynamic) correlations, if applicable and to evaluate the pharmacogenomic (PGx) expression profile of selected putative markers potentially predictive of response to PM01183, in tissues from tumor samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PM01183 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM01183 | Drug | PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions. | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
| Overall Response | Overall Response Rate (ORR) in the population evaluable for efficacy according to RECIST v.1.1. ORR was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions; SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; TF, treatment failure. | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. |
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Inclusion Criteria:
At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy
Exclusion Criteria:
History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).
Known muscular disease or functional alteration
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Women's Cancer Center | Stanford | California | 94305 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33914350 | Derived | Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9. | |
| 30240327 | Derived |
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The first patient was included on 27JUN12 and the first study treatment administration was on 28JUN12.
The cutoff date for the results was 24OCT18. A total of 111 patients were included in the 3 cohorts of the study: 56 in Cohort A (BRCA+), 20 in Cohort A1 (BRCA+/PARPi), 35 in Cohort B (Unselected).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (BRCA+) | Patients with known deleterious BRCA1/2 mutation status at study entry |
| FG001 | Cohort A1 (BRCA+/PARPi) | Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi. |
| FG002 | Cohort B (Unselected) | Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (BRCA+) | Patients with known deleterious BRCA1/2 mutation status at study entry |
| BG001 | Cohort A1 (BRCA+/PARPi) | Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi. |
| 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 |
| 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) | The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
|
Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A (BRCA+) | Patients with known deleterious BRCA1/2 mutation status at study entry |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharma Mar S.A. | Pharma Mar S.A. | 00 34 91846 60 00 | clinicaltrials@pharmamar.com |
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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 | Mar 8, 2016 | Jul 20, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2018 | Jul 20, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C568606 | PM 01183 |
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| Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
| Duration of Response Rate at 6 Months | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. | Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 6 months |
| Duration of Response Rate at 12 Months | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. | Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 12 months |
| Clinical Benefit Rate | Clinical benefit, defined as the percentage of patients with ORR or SD lasting over three months (SD >3 months). The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions. SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
| Progression-free Survival (PFS) | Progression-free survival (PFS) is defined as the period of time from the date of first infusion to the date of progression disease, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 36 months |
| Progression-free Survival at 3 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 3 months |
| Progression-free Survival at 6 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 6 months |
| Progression-free Survival at 12 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 12 months |
| 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 | 36 months |
| Overall Survival Rate at 12 Months | Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact | Time from the date of first infusion to the date of death or last contact, up to 12 months |
| Overall Survival Rate at 18 Months | Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact. | Time from the date of first infusion to the date of death or last contact, up to 18 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Abramson Cancer Center - Hospital of the University of Pennsylvania at Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Complexo Hospitalario Universitario A Coruña | A Coruña | A Coruña | 15006 | Spain |
| Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| Cruz C, Llop-Guevara A, Garber JE, Arun BK, Perez Fidalgo JA, Lluch A, Telli ML, Fernandez C, Kahatt C, Galmarini CM, Soto-Matos A, Alfaro V, Perez de la Haza A, Domchek SM, Antolin S, Vahdat L, Tung NM, Lopez R, Arribas J, Vivancos A, Baselga J, Serra V, Balmana J, Isakoff SJ. Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy. J Clin Oncol. 2018 Nov 1;36(31):3134-3143. doi: 10.1200/JCO.2018.78.6558. Epub 2018 Sep 21. |
| Never treated |
|
| Physician Decision |
|
| Death |
|
| Treatment-related AE |
|
| Other reasons |
|
| Withdrawal by Subject |
|
| BG002 | Cohort B (Unselected) | Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
| Sites of disease at diagnosis | Count of Participants | Participants |
|
| Histology type at diagnosis | Count of Participants | Participants |
|
| Histology grade at diagnosis | Well differentiated: The cells are slower-growing, and look more like normal breast tissue. Moderately differentiated: The cells are growing at a speed of and look like cells somewhere between grades 1 and 3. Poorly differentiated: The cancer cells look very different from normal cells and will probably grow and spread faster. | Count of Participants | Participants |
|
| Stage at diagnosis | Stage I describes invasive breast cancer (cancer cells are breaking through to or invading normal surrounding breast tissue) Stage II. The cancer has grown, spread, or both. Stage III. The cancer has not spread to bones or organs, but it's considered advanced, and it's harder to fight. Stage IV describes invasive breast cancer that has spread beyond the breast and nearby lymph nodes to other organs of the body, such as the lungs, distant lymph nodes, skin, bones, liver, or brain. | Count of Participants | Participants |
|
| BRCA deleterious mutation | Count of Participants | Participants |
|
| Hormonal status | Count of Participants | Participants |
|
| Sites at baseline | Count of Participants | Participants |
|
| Prior surgery | Count of Participants | Participants |
|
| Prior radiotherapy | 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 |
|
| Number of sites at baseline | Median | Full Range | sites |
|
| Time from first diagnosis to registration | Median | Full Range | months |
|
| Time from metastatic disease to registration | Median | Full Range | months |
|
| Time from last progression before study entry | Median | Full Range | weeks |
|
| OG001 |
| Cohort A1 (BRCA+/PARPi) |
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi. |
| OG002 | Cohort B (Unselected) | Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:
|
|
|
| Primary | Overall Response | Overall Response Rate (ORR) in the population evaluable for efficacy according to RECIST v.1.1. ORR was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions; SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; TF, treatment failure. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Count of Participants | Participants | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
|
|
|
| Secondary | Duration of Response | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. | Responder patients (PR or CR, whichever was first reached) | Posted | Median | 95% Confidence Interval | months | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
|
|
|
|
| Secondary | Duration of Response Rate at 6 Months | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. | Responder patients | Posted | Number | 95% Confidence Interval | percentage of participants | Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 6 months |
|
|
|
| Secondary | Duration of Response Rate at 12 Months | Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions. | Responder patients | Posted | Number | 95% Confidence Interval | percentage of participants | Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 12 months |
|
|
|
| Secondary | Clinical Benefit Rate | Clinical benefit, defined as the percentage of patients with ORR or SD lasting over three months (SD >3 months). The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions. SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) is defined as the period of time from the date of first infusion to the date of progression disease, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Median | 95% Confidence Interval | months | 36 months |
|
|
|
|
| Secondary | Progression-free Survival at 3 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 3 months |
|
|
|
| Secondary | Progression-free Survival at 6 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 6 months |
|
|
|
| Secondary | Progression-free Survival at 12 Months | Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 12 months |
|
|
|
| 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 | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Median | 95% Confidence Interval | months | 36 months |
|
|
|
|
| Secondary | Overall Survival Rate at 12 Months | Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of first infusion to the date of death or last contact, up to 12 months |
|
|
|
| Secondary | Overall Survival Rate at 18 Months | Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact. | Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments | Posted | Number | 95% Confidence Interval | percentage of participants | Time from the date of first infusion to the date of death or last contact, up to 18 months |
|
|
|
| 40 |
| 54 |
| 14 |
| 54 |
| 54 |
| 54 |
| EG001 | Cohort A1 (BRCA+/PARPi) | Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi. | 13 | 20 | 5 | 20 | 20 | 20 |
| EG002 | Cohort B (Unselected) | Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:
| 30 | 35 | 8 | 35 | 34 | 35 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myelitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Listeriosis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| diplopia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| odynophagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sputum purulent | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA (15.0) | 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
| D017437 |
| Skin and Connective Tissue Diseases |
| SD |
|
| PD |
|
| TF |
|