Trial Outcomes & Findings for Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study (NCT NCT04197713)

NCT ID: NCT04197713

Last Updated: 2025-10-17

Results Overview

The number of patients who had dose limiting toxicity (DLT). DLT was defined as grade ≥3 non-hematological toxicity, grade 3 fatigue of greater than 1 week duration, failure to receive at least 70% of dosing due to trial drug-related toxicities, or experiencing a drug-related toxicity that meets criteria for a DLT, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, grade 4 neutropenia ≥5 days or febrile neutropenia, Any degree of anemia, leukopenia in the absence of grade 4 neutropenia ≥4 days.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Within the first cycle (28 days) of treatment

Results posted on

2025-10-17

Participant Flow

This was a single site, phase I study performed at MD Anderson Cancer Center in Houston, TX. Patients were eligible to enroll in (1) the dose escalation part of the study if they had advanced solid tumors for which curative measures did not exist or were no longer effective, or (2) the dose expansion part of the study if they had advanced solid tumors with actionable DNA Damage Response mutations. The dose escalation part of the study also recruited those with relevant mutations (not mandatory).

Thirteen patients were treated on-study in the dose escalation part of the study: three were treated at dose level 1 (DL1) and ten were treated at dose level 2 (DL2). One patient treated in DL2 was not evaluable for dose limiting toxicity (DLT) because this patient did not receive more than 70% of study drug in the first cycle. The remaining nine patients were evaluable for DLT. The DLT window was within the first cycle (28 days) of treatment.

Participant milestones

Participant milestones
Measure	Dose Level 1 (DL1) DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Overall Study STARTED	3	10
Overall Study COMPLETED	3	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 (DL1) DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Overall Study Not evaluable for DLT per protocol (dosing less than 70% of the study drug in first cycle)	0	1

Baseline Characteristics

Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Within the first cycle (28 days) of treatment

Population: 12 patients (3 in DL1 and 9 in DL2) completed the evaluability period and dosed more than 70% of study drug in the first cycle and were thus included in the DLT analyses. 1 patient at dose level 2 was not evaluable for DLT because this patient did not receive more than 70% of study drug in the first cycle.

Outcome measures

Outcome measures
Measure	Dose Level 1 (DL1) n=3 Participants DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4) Patients receive olaparib PO BID on days 1-5 and 15-19 of each cycle and adavosertib PO QD on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Adavosertib: Given PO Olaparib: Given PO	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Dose Limiting Toxicity DLT	0 Participants	0 Participants	—	—	—	—	—
Dose Limiting Toxicity No DLT	3 Participants	9 Participants	—	—	—	—	—
Dose Limiting Toxicity Not evaluable for DLT	0 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Approximately 2 years and 7 months. For each enrolled patient, adverse event data was captured from the period in which a patient signed the informed consent and up to 90 days after the administration of the last dose of study drug.

The data represents the number of patients with reported treatment-related adverse events that were deemed at least possibly, probably, or definitely related to study treatment, and were graded based on the Common Terminology Criteria for Adverse Events, Version 5(CTCAE 5.0). Only the highest grade assigned for each treatment-related adverse event is reported.

Outcome measures

Outcome measures
Measure	Dose Level 1 (DL1) n=3 Participants DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=3 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4) n=3 Participants Patients receive olaparib PO BID on days 1-5 and 15-19 of each cycle and adavosertib PO QD on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Adavosertib: Given PO Olaparib: Given PO	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Incidence and Causality of Treatment-Related Adverse Events Anemia	2 adverse events	0 adverse events	0 adverse events	6 adverse events	1 adverse events	0 adverse events	1 adverse events
Incidence and Causality of Treatment-Related Adverse Events Nausea	2 adverse events	1 adverse events	0 adverse events	4 adverse events	3 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Vomiting	1 adverse events	0 adverse events	0 adverse events	4 adverse events	2 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Fatigue	0 adverse events	1 adverse events	0 adverse events	3 adverse events	2 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Diarrhea	2 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	1 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Anorexia	0 adverse events	0 adverse events	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Neutrophil count decreased	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	1 adverse events
Incidence and Causality of Treatment-Related Adverse Events Platelet count decreased	0 adverse events	0 adverse events	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events White blood cell decreased	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	1 adverse events
Incidence and Causality of Treatment-Related Adverse Events Abdominal pain	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Lipase increased	0 adverse events	0 adverse events	1 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Creatinine increased	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Dyspepsia	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Headache	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Hypotension	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Pain in extremity	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Incidence and Causality of Treatment-Related Adverse Events Serum amylase increased	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: The MTD will be identified in the dose escalation phase. Once identified, the MTD will be used by the dose expansion cohorts through study completion, which will take place for approximately 2 years after MTD is identified.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

Population: 12 participants (3 in DL1 and 9 in DL2) completed the evaluability period and dosed more than 70% of study drug in the first cycle and were thus included in the response analyses. 1 participant was not evaluable because this participant did not receive more than 70% of study drug in the first cycle.

Objective response (OR) was defined as percent of patients that achieve complete response (CR, measured as the disappearance of all target lesions), or partial response (PR, measured as ≥30% decrease in the sum of the diameters of target lesions), and it was assessed as best response per RECIST 1.1 from start of treatment until disease progression/recurrence.

Outcome measures

Outcome measures
Measure	Dose Level 1 (DL1) n=3 Participants DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4) Patients receive olaparib PO BID on days 1-5 and 15-19 of each cycle and adavosertib PO QD on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Adavosertib: Given PO Olaparib: Given PO	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Objective Response Rate Objective response (Complete response + Partial response)	0 Participants	2 Participants	—	—	—	—	—
Objective Response Rate No objective response (Stable disease + Progressive disease)	3 Participants	7 Participants	—	—	—	—	—
Objective Response Rate Not evaluable	0 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

Population: 12 participants (3 in DL1 and 9 in DL2) completed the evaluability period and dosed more than 70% of study drug in the first cycle and were thus included in the response analyses. 1 participants was not evaluable for the dose limiting toxicity (DLT) period because this participants did not receive more than 70% of study drug in the first cycle.

Clinical benefit, assessed as best response per RECIST 1.1 and defined as percent of patients that achieve complete response (disappearance of all target lesions), partial response (≥30% decrease in the sum of the diameters of target lesions) or stable disease (neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters) lasting for more than 6 months.

Outcome measures

Outcome measures
Measure	Dose Level 1 (DL1) n=3 Participants DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4) Patients receive olaparib PO BID on days 1-5 and 15-19 of each cycle and adavosertib PO QD on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Adavosertib: Given PO Olaparib: Given PO	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4) DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Clinical Benefit Not evaluable	0 Participants	1 Participants	—	—	—	—	—
Clinical Benefit Clinical benefit	0 Participants	2 Participants	—	—	—	—	—
Clinical Benefit No clnical benefit	3 Participants	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From treatment start to progression or death, whichever occurred first or to the last imaging scan.

Progression-free survival was defined as the time between the start of treatment and (i) the time of progression (defined using RECIST v1.1. as a 20% increase in the sum of the longest diameter of target lesions and an absolute increase of at least 5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurred first; or (ii) the time to the last imaging scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

Overall survival was defined as from the time of treatment start to the time of death or last follow-up.

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1 (DL1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 2 (DL2)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 (DL1) n=3 participants at risk DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=10 participants at risk DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Ascites	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
General disorders Fever	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Nausea	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Vomiting	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
General disorders Tumor pain	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Constipation	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Blood and lymphatic system disorders Platelet count decreased	33.3% 1/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	0.00% 0/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial	10.0% 1/10 • Time elapsed between the time the patient signed the informed consent and up to 90 days after the last administration of the last dose of study drug, for a period of approximately 3 years. All adverse events of all grades (1-4) and any attribution were reported; no grade 5 AEs were recorded/reported on this trial

Other adverse events

Additional Information

Dr. Timothy Yap

University of M D Anderson Cancer Center

Phone: 713) 563-1784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Dose Level 1 (DL1) n=3 Participants DL1: Olaparib 300 mg BID Days 1-5 and 15-19+ AZD1775 250 mg QD Days 8-12 and 22-26 ; 28-day cycle	Dose Level 2 (DL2) n=10 Participants DL2: Olaparib 300 mg BID Days 1-5 and 15-19 + AZD1775 300 mg QD Days 8-12 and 22-26; 28-day cycle	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	61 Years n=5 Participants	50.5 Years n=7 Participants	52 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants