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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003722-13 | EudraCT Number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.
This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing four dose levels of Olaparib given with concomitant radiotherapy, followed by an expansion cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib in association with concomitant radiotherapy | Experimental | Olaparib will be administered per os bi-daily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | We reported in the following the number of Participants who experienced DLT. A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills all the criteria below: 1/ Occurs during the period of observation of DLTs defined as the period between the first day of treatment administration and up to 6 weeks after the end of radiotherapy. 2/ Is considered to be at least possibly related to the treatment strategy (radiotherapy or Olaparib).3/ Is unrelated to disease, disease progression, inter-current illness, or concomitant medications. 4/ Meets some criteria (see protocole), graded according to NCI CTCAEv4.0 | Until to six weeks after end of radiotherapy |
| Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy | MTD was determined by testing increasing doses up 150mg twice a day on dose escalation cohorts 1 to 4 with 3 to 11 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) that could be related to treatment (reported in the following primary outcome measure). | Up to 6 weeks after end of radiotherapy for each dosing cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Non-progression at 6 Months as Per RECIST 1.1 | 6-month non progression rate is defined as the proportion of complete (CR) or partial response (PR) at 6 months confirmed ≥ 4 weeks after initial documentation, or stable disease (SD) more than 24 weeks (RECIST v1.1, as determined by investigator review of tumor assessments). | up to 6-month after treatment onset |
Not provided
Inclusion Criteria:
Histology: patients with soft-tissue sarcoma histologically confirmed by central review (Pr Coindre team), except if the diagnosis was already confirmed by the RRePS Network,
Upper/Lower limb or trunk wall soft-tissue sarcoma,
Age ≥ 18 years,
Locally advanced or locally recurrent primitive tumor, outside any previously irradiated field. Patients presenting operable locally Advanced or lacally recurrent tumor can be included. Patients with metastases can be included.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,
Life expectancy ≥ 6 months,
At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements,
Adequate hematological, renal, metabolic and hepatic function:
Women of childbearing potential must have a negative serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Female patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 1 month after last dose of study drug. Males patients, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 3 month after last dose of study drug. Acceptable birth control methods are described in appendix 10.
Subjects of non-childbearing potential are those who have:
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up,
Voluntary signed and dated written informed consent prior to any specific procedure,
Patients with a social security in compliance with the Law.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France | |||
| Centre Léon Bérard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39894354 | Result | Sargos P, Sunyach MP, Ducassou A, Llacer C, Dinart D, Michot A, Valentin T, Firmin N, Blay JY, Gillon P, Bellera C, Italiano A. Results of a phase Ib study of olaparib with concomitant radiotherapy in soft-tissue sarcoma: a French sarcoma group study. Ann Oncol. 2025 May;36(5):592-600. doi: 10.1016/j.annonc.2025.01.016. Epub 2025 Jan 31. | |
| 32827353 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 25mg + Radiotherapy | Participants were administered 25mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| FG001 | Olaparib 50mg + Radiotherapy | Participants were administered 50mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| FG002 | Olaparib 100mg + Radiotherapy | Participants were administered 100mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| FG003 | Olaparib 150mg + Radiotherapy | Participants were administered 150mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 25mg + Radiotherapy | Participants were administered 25mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | We reported in the following the number of Participants who experienced DLT. A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills all the criteria below: 1/ Occurs during the period of observation of DLTs defined as the period between the first day of treatment administration and up to 6 weeks after the end of radiotherapy. 2/ Is considered to be at least possibly related to the treatment strategy (radiotherapy or Olaparib).3/ Is unrelated to disease, disease progression, inter-current illness, or concomitant medications. 4/ Meets some criteria (see protocole), graded according to NCI CTCAEv4.0 | Dose escalation study assessing four doses level of Olaparib (25mg, 50mg, 100mg, 150mg) in association with concomitant radiotherapy. | Posted | Count of Participants | Participants | Until to six weeks after end of radiotherapy |
|
through study completion, an average of 13.5 weeks
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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 | Olaparib 25 mg + Radiotherapy | All participants who received 25 mg twice a day of Olaparib in association with concomitant radiotherapy during the dose-escalation part of the study. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAEv4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAEv4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Coordinating Investigator | Institut Bergonie | 05.56.33.33.33 | p.sargos@bordeaux.unicancer.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2021 | Sep 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2021 | Sep 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
Not provided
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|
| Concomitant Radiotherapy | Radiation | Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
|
| Percentage of Participants With Objective Responses at 6 Months as Per RECIST 1.1 | 6-month objective response, defined as CR or PR at 6 months confirmed ≥ 4 weeks after initial documentation, as determined by investigator review of tumor assessments using RECIST v1.1 | up to 6-month after treatment onset |
| Best Response Under Treatment as Per RECIST 1.1 | Best response under treatment is defined as the best response (CR, PR, SD) as per RECIST 1.1 recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria. It is determined once all the data for the patient is known. | End of treatment, approximately 13.5 weeks atfer treatment onset |
| Progression-free Survival (PFS) as Per RECIST 1.1 | PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. | 1 year after treatment onset |
| Overall Survival (OS) | OS is defined as the time from study treatment initiation to death (of any cause). | 1 year after treatment onset |
| Musculoskeletal Tumor Society (MSTS) Functional Score | The Musculoskeletal Tumor Society (MSTS) score assesses functional outcomes before (week 2) and after (week 10) treatment with olaparib in combination with radiotherapy. It consists of six items (pain, function, emotional acceptance, and either support/walking/gait for lower limbs or positioning/dexterity/strength for upper limbs). Each item is rated 0-5, summed to a total score ranging from 0 (worst outcome) to 30 (best outcome). Higher scores represent better functional outcomes. | Two weeks after treatment onset |
| Lyon |
| 69373 |
| France |
| Institut du Cancer de Montpellier | Montpellier | 34298 | France |
| Institut Claudius Regaud - IUCT | Toulouse | 31052 | France |
| Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22. |
| Disease progression |
|
| BG001 | Olaparib 50mg + Radiotherapy | Participants were administered 50mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| BG002 | Olaparib 100mg + Radiotherapy | Participants were administered 100mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| BG003 | Olaparib 150mg + Radiotherapy | Participants were administered 150mg per os bidaily, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
All participants who received 25mg of Olaparib in association with concomitant radiotherapy and assesable for DLT |
| OG001 | Olaparib 50mg + Radiotherapy | All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT |
| OG002 | Olaparib 100mg + Radiotherapy | All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT |
| OG003 | Olaparib 150mg + Radiotherapy | All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT |
|
|
| Primary | Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy | MTD was determined by testing increasing doses up 150mg twice a day on dose escalation cohorts 1 to 4 with 3 to 11 participants each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) that could be related to treatment (reported in the following primary outcome measure). | Posted | Number | mg | Up to 6 weeks after end of radiotherapy for each dosing cohort |
|
|
|
| Secondary | Percentage of Participants With Non-progression at 6 Months as Per RECIST 1.1 | 6-month non progression rate is defined as the proportion of complete (CR) or partial response (PR) at 6 months confirmed ≥ 4 weeks after initial documentation, or stable disease (SD) more than 24 weeks (RECIST v1.1, as determined by investigator review of tumor assessments). | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 6-month after treatment onset |
|
|
|
| Secondary | Percentage of Participants With Objective Responses at 6 Months as Per RECIST 1.1 | 6-month objective response, defined as CR or PR at 6 months confirmed ≥ 4 weeks after initial documentation, as determined by investigator review of tumor assessments using RECIST v1.1 | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Number | 97.5% Confidence Interval | percentage of participants | up to 6-month after treatment onset |
|
|
|
| Secondary | Best Response Under Treatment as Per RECIST 1.1 | Best response under treatment is defined as the best response (CR, PR, SD) as per RECIST 1.1 recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria. It is determined once all the data for the patient is known. | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Count of Participants | Participants | End of treatment, approximately 13.5 weeks atfer treatment onset |
|
|
|
| Secondary | Progression-free Survival (PFS) as Per RECIST 1.1 | PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Number | 95% Confidence Interval | proportion of participants | 1 year after treatment onset |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as the time from study treatment initiation to death (of any cause). | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Number | 95% Confidence Interval | proportion of participants | 1 year after treatment onset |
|
|
|
| Secondary | Musculoskeletal Tumor Society (MSTS) Functional Score | The Musculoskeletal Tumor Society (MSTS) score assesses functional outcomes before (week 2) and after (week 10) treatment with olaparib in combination with radiotherapy. It consists of six items (pain, function, emotional acceptance, and either support/walking/gait for lower limbs or positioning/dexterity/strength for upper limbs). Each item is rated 0-5, summed to a total score ranging from 0 (worst outcome) to 30 (best outcome). Higher scores represent better functional outcomes. | Analyses of efficacy outcomes were conducted on the pooled dose-escalation (DE) population rather than separately by individual dose cohorts. This approach was prespecified in the study protocol and statistical analysis plan. The DE cohorts were not designed to function as independent or comparative treatment arms. Reporting efficacy outcomes separately by dose cohort would result in extremely small and clinically non-interpretable sample sizes and could be misleading. | Posted | Mean | Standard Deviation | score on a scale | Two weeks after treatment onset |
|
|
|
| 3 |
| 5 |
| 4 |
| 5 |
| 5 |
| 5 |
| EG001 | Olaparib 50 mg + Radiotherapy | All participants who received 50 mg twice a day of Olaparib in association with concomitant radiotherapy during the dose-escalation part of the study. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. | 4 | 7 | 5 | 7 | 7 | 7 |
| EG002 | Olaparib 100 mg + Radiotherapy | All participants who received 100 mg twice a day of Olaparib in association with concomitant radiotherapy during the dose-escalation part of the study. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. | 3 | 11 | 5 | 11 | 11 | 11 |
| EG003 | Olaparib 150 mg + Radiotherapy | All participants who received 150 mg twice a day of Olaparib in association with concomitant radiotherapy during the dose-escalation part of the study. Concomitant Radiotherapy: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8. | 1 | 3 | 1 | 3 | 3 | 3 |
| Erysipelas | Infections and infestations | CTCAEv4.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAEv4.0 | Systematic Assessment |
|
| Radioepithelite | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Massive blood hemorrhage | Vascular disorders | CTCAEv4.0 | Systematic Assessment |
|
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4.0 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4.0 | Systematic Assessment |
|
| Depression due to problem family | Psychiatric disorders | CTCAEv4.0 | Systematic Assessment |
|
| Epithelite | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Malaise (disconfort) | General disorders | CTCAEv4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAEv4.0 | Systematic Assessment |
|
| Post radiation oesophagus stenosis | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Problem of reflux of PICC | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | CTCAEv4.0 | Systematic Assessment |
|
| Worsening of anemia | Blood and lymphatic system disorders | CTCAEv4.0 | Systematic Assessment |
|
| Acute febrile respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Bursting of myxofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAEv4.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Cutaneous necrosis | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAEv4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAEv4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAEv4.0 | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAEv4.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAEv4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAEv4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAEv4.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAEv4.0 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | CTCAEv4.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAEv4.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAEv4.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAEv4.0 | Systematic Assessment |
|
Not provided
Not provided
| Male |
|
| Inevaluable for response |
|