Trial Outcomes & Findings for A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma (NCT NCT02787642)

Last Updated: 2026-02-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Until to six weeks after end of radiotherapy

Results posted on

2026-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	5	7	11	3
Overall Study COMPLETED	4	7	10	3
Overall Study NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Adverse Event	0	0	1	0
Overall Study Disease progression	1	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib 25mg + Radiotherapy n=5 Participants 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.	Olaparib 50mg + Radiotherapy n=7 Participants 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.	Olaparib 100mg + Radiotherapy n=11 Participants 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.	Olaparib 150mg + Radiotherapy n=3 Participants 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.	Total n=26 Participants Total of all reporting groups
Age, Continuous Age by group	71 years n=5 Participants	66 years n=7 Participants	73 years n=11 Participants	54 years n=3 Participants	70 years n=26 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=11 Participants	2 Participants n=3 Participants	16 Participants n=26 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=11 Participants	1 Participants n=3 Participants	10 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Until to six weeks after end of radiotherapy

Population: Dose escalation study assessing four doses level of Olaparib (25mg, 50mg, 100mg, 150mg) in association with concomitant radiotherapy.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy n=7 Participants All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy n=10 Participants All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy n=3 Participants All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	1 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks after end of radiotherapy for each dosing cohort

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).

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy	100 mg	—	—	—

SECONDARY outcome

Timeframe: up to 6-month after treatment onset

Population: 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.

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).

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Percentage of Participants With Non-progression at 6 Months as Per RECIST 1.1	19.2 percentage of participants Interval 6.5 to 39.3	—	—	—

SECONDARY outcome

Timeframe: up to 6-month after treatment onset

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

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Percentage of Participants With Objective Responses at 6 Months as Per RECIST 1.1	0 percentage of participants Interval 0.0 to 13.2	—	—	—

SECONDARY outcome

Timeframe: End of treatment, approximately 13.5 weeks atfer treatment onset

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.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Best Response Under Treatment as Per RECIST 1.1 Partial response	1 Participants	—	—	—
Best Response Under Treatment as Per RECIST 1.1 Stable disease	21 Participants	—	—	—
Best Response Under Treatment as Per RECIST 1.1 Progressive disease	2 Participants	—	—	—
Best Response Under Treatment as Per RECIST 1.1 Inevaluable for response	2 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 year after treatment onset

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.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Progression-free Survival (PFS) as Per RECIST 1.1	0.50 proportion of participants Interval 0.3 to 0.67	—	—	—

SECONDARY outcome

Timeframe: 1 year after treatment onset

OS is defined as the time from study treatment initiation to death (of any cause).

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Overall Survival (OS)	0.69 proportion of participants Interval 0.48 to 0.83	—	—	—

SECONDARY outcome

Timeframe: Two weeks after treatment onset

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.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants who received either 25mg, 50mg, 100mg or 150mg of Olaparib in association with concomitant radiotherapy during the dose-escalation part.	Olaparib 50mg + Radiotherapy All participants who received 50mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 100mg + Radiotherapy All participants who received either 100mg of Olaparib in association with concomitant radiotherapy and assesable for DLT	Olaparib 150mg + Radiotherapy All participants who received 150mg of Olaparib in association with concomitant radiotherapy and assesable for DLT
Musculoskeletal Tumor Society (MSTS) Functional Score	16.5 score on a scale Standard Deviation 10.3	—	—	—

Adverse Events

Olaparib 25 mg + Radiotherapy

Serious events: 4 serious events

Other events: 5 other events

Deaths: 3 deaths

Olaparib 50 mg + Radiotherapy

Serious events: 5 serious events

Other events: 7 other events

Deaths: 4 deaths

Olaparib 100 mg + Radiotherapy

Serious events: 5 serious events

Other events: 11 other events

Deaths: 3 deaths

Olaparib 150 mg + Radiotherapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Coordinating Investigator

Institut Bergonie

Phone: 05.56.33.33.33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Olaparib 25 mg + Radiotherapy n=5 participants at risk 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.	Olaparib 50 mg + Radiotherapy n=7 participants at risk 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.	Olaparib 100 mg + Radiotherapy n=11 participants at risk 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.	Olaparib 150 mg + Radiotherapy n=3 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Infections and infestations Erysipelas	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Metabolism and nutrition disorders Anorexia	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Radioepithelite	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Vascular disorders Massive blood hemorrhage	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Psychiatric disorders Depression due to problem family	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Epithelite	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
General disorders Malaise (disconfort)	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Gastrointestinal disorders Vomiting	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Post radiation oesophagus stenosis	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Problem of reflux of PICC	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Nervous system disorders Cerebral haemorrhage	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Blood and lymphatic system disorders Worsening of anemia	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Respiratory, thoracic and mediastinal disorders Acute febrile respiratory distress	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bursting of myxofibrosarcoma	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Cutaneous necrosis	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks

Measure	Olaparib 25 mg + Radiotherapy n=5 participants at risk 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.	Olaparib 50 mg + Radiotherapy n=7 participants at risk 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.	Olaparib 100 mg + Radiotherapy n=11 participants at risk 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.	Olaparib 150 mg + Radiotherapy n=3 participants at risk 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.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	57.1% 4/7 • Number of events 4 • through study completion, an average of 13.5 weeks	27.3% 3/11 • Number of events 3 • through study completion, an average of 13.5 weeks	66.7% 2/3 • Number of events 2 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Dermatitis radiation	100.0% 5/5 • Number of events 5 • through study completion, an average of 13.5 weeks	100.0% 7/7 • Number of events 9 • through study completion, an average of 13.5 weeks	81.8% 9/11 • Number of events 12 • through study completion, an average of 13.5 weeks	100.0% 3/3 • Number of events 3 • through study completion, an average of 13.5 weeks
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	27.3% 3/11 • Number of events 3 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Blood and lymphatic system disorders Anemia	40.0% 2/5 • Number of events 2 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 2 • through study completion, an average of 13.5 weeks
Gastrointestinal disorders Constipation	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Gastrointestinal disorders Dysphagia	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Gastrointestinal disorders Mucositis oral	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Gastrointestinal disorders Nausea	40.0% 2/5 • Number of events 3 • through study completion, an average of 13.5 weeks	28.6% 2/7 • Number of events 3 • through study completion, an average of 13.5 weeks	45.5% 5/11 • Number of events 7 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
General disorders Edema limbs	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	28.6% 2/7 • Number of events 2 • through study completion, an average of 13.5 weeks	45.5% 5/11 • Number of events 5 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Investigations Lymphocyte count decreased	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Investigations Platelet count decreased	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/11 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Metabolism and nutrition disorders Anorexia	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	27.3% 3/11 • Number of events 3 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Musculoskeletal and connective tissue disorders Myositis	40.0% 2/5 • Number of events 2 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 2 • through study completion, an average of 13.5 weeks	54.5% 6/11 • Number of events 6 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	33.3% 1/3 • Number of events 1 • through study completion, an average of 13.5 weeks
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/7 • through study completion, an average of 13.5 weeks	9.1% 1/11 • Number of events 1 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks
Skin and subcutaneous tissue disorders Skin hyperpigmentation	20.0% 1/5 • Number of events 1 • through study completion, an average of 13.5 weeks	14.3% 1/7 • Number of events 1 • through study completion, an average of 13.5 weeks	18.2% 2/11 • Number of events 2 • through study completion, an average of 13.5 weeks	0.00% 0/3 • through study completion, an average of 13.5 weeks