Who is sponsoring NCT04197713?

NCT04197713 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT04197713?

Interventions in NCT04197713: Adavosertib, Olaparib.

What condition does NCT04197713 study?

NCT04197713 studies Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.

Is NCT04197713 still recruiting?

NCT04197713 is currently active, enrolled. Last updated 20 October 2025.

Are results published for NCT04197713?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-20 · How we verify

NCT04197713

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 1 Results posted Last updated 20 October 2025

What this trial tests

Phase 1 trial testing Adavosertib in Advanced Malignant Solid Neoplasm in 13 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 June 2020

Primary endpoint
22 February 2023

30 September 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	30 June 2020
Primary completion	22 February 2023
Estimated completion	30 September 2026
Sites	1 location across United States

Drugs / interventions tested

Adavosertib — full drug profile →
Olaparib (olaparib) — full drug profile →

Conditions studied

Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
Refractory Malignant Solid Neoplasm — all drugs for Refractory Malignant Solid Neoplasm →
Unresectable Malignant Solid Neoplasm — all drugs for Unresectable Malignant Solid Neoplasm →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Advanced Malignant Solid Neoplasm or Metastatic Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose Limiting Toxicity Primary · Within the first cycle (28 days) of treatment

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.

DLT

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	0

No DLT

Group	Value	95% CI
Dose Level 1 (DL1)	3
Dose Level 2 (DL2)	9

Not evaluable for DLT

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	1

Incidence and Causality of Treatment-Related Adverse Events Primary · 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.

Anemia

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	2
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	6
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	1

Nausea

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	2
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	1
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	4
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	3
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Vomiting

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	1
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	4
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	2
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Fatigue

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	1
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	3
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	2
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Diarrhea

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	2
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	2
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Anorexia

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	2
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Neutrophil count decreased

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	1

Platelet count decreased

Group	Value	95% CI
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 1)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 2)	0
DL1 - Olaparib 300 mg + AZD1775 250 mg (Grade 4)	1
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 1)	2
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 2)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 3)	0
DL2 - Olaparib 300 mg + AZD1775 300 mg (Grade 4)	0

Objective Response Rate Secondary · 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.

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.

Objective response (Complete response + Partial response)

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	2

No objective response (Stable disease + Progressive disease)

Group	Value	95% CI
Dose Level 1 (DL1)	3
Dose Level 2 (DL2)	7

Not evaluable

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	1

Clinical Benefit Secondary · 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.

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.

Clinical benefit

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	2

No clnical benefit

Group	Value	95% CI
Dose Level 1 (DL1)	3
Dose Level 2 (DL2)	7

Not evaluable

Group	Value	95% CI
Dose Level 1 (DL1)	0
Dose Level 2 (DL2)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Level 1 (DL1)

Serious: 1/3 (33%)

Deaths: 3/3

Dose Level 2 (DL2)

Serious: 5/10 (50%)

Deaths: 5/10

Serious adverse events (12 terms)

Reaction	System	Dose Level 1 (DL1)	Dose Level 2 (DL2)
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Fever	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Tumor pain	General disorders	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Platelet count decreased	Blood and lymphatic system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—

Other adverse events (61 terms — click to expand)

Reaction	System	Dose Level 1 (DL1)	Dose Level 2 (DL2)
Anemia	Blood and lymphatic system disorders	—	—
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
ALT increased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Sinus tachycardia	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Platelet count decreased	Investigations	—	—
White blood cell decreased	Investigations	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
AST increased	Investigations	—	—
Creatinine increased	Investigations	—	—
Lipase increased	Investigations	—	—
Serum amylase increased	Investigations	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Insomnia	General disorders	—	—
Renal & urinary disorders - Other, specify - abnormal UA	Renal and urinary disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Edema limbs	General disorders	—	—
Fever	General disorders	—	—
Bloating	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Sinusitis	Infections and infestations	—	—
Thrush	Infections and infestations	—	—
Injury/poison/procedure - Other - Toe injury	General disorders	—	—
Blood bilirubin increased	Investigations	—	—
Investigations - Other, specify - Vitamin D Deficiency	Investigations	—	—
Weight loss	Investigations	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Hypernatremia	Metabolism and nutrition disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Pain in extremity, Ascites, Fever, Abdominal pain, Nausea, Vomiting, Tumor pain, Small intestinal obstruction.

Data from ClinicalTrials.gov NCT04197713 adverse events section.

Sponsor's own description

This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body (advanced) with selected mutations. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving olaparib and adavosertib one after the other may shrink or stabilize advanced solid tumors as successfully as using them together, with fewer side effects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

PARP inhibitor resistance: the underlying mechanisms and clinical implications.
Li H, Liu ZY, Wu N, Chen YC, et al · · 2020 · cited 379× · PMID 32563252 · DOI 10.1186/s12943-020-01227-0
Targeting replication stress in cancer therapy.
da Costa AABA, Chowdhury D, Shapiro GI, D'Andrea AD, et al · · 2023 · cited 274× · PMID 36202931 · DOI 10.1038/s41573-022-00558-5
A WEE1 family business: regulation of mitosis, cancer progression, and therapeutic target.
Ghelli Luserna di Rorà A, Cerchione C, Martinelli G, Simonetti G. · · 2020 · cited 232× · PMID 32958072 · DOI 10.1186/s13045-020-00959-2
Biomarker-Guided Development of DNA Repair Inhibitors.
Cleary JM, Aguirre AJ, Shapiro GI, D'Andrea AD. · · 2020 · cited 192× · PMID 32459988 · DOI 10.1016/j.molcel.2020.04.035
Cell cycle checkpoints and beyond: Exploiting the ATR/CHK1/WEE1 pathway for the treatment of PARP inhibitor-resistant cancer.
Gupta N, Huang TT, Horibata S, Lee JM. · · 2022 · cited 89× · PMID 35259479 · DOI 10.1016/j.phrs.2022.106162
PARP Inhibitors: Clinical Limitations and Recent Attempts to Overcome Them.
Kim D, Nam HJ. · · 2022 · cited 88× · PMID 35955544 · DOI 10.3390/ijms23158412
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
Targeting the replication stress response through synthetic lethal strategies in cancer medicine.
Ngoi NYL, Pham MM, Tan DSP, Yap TA. · · 2021 · cited 78× · PMID 34215565 · DOI 10.1016/j.trecan.2021.06.002

Verify or expand the search:

Other trials of Adavosertib

Trials testing the same drug.

NCT04949425 — A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours · Phase 1 · terminated
NCT04959266 — A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib · Phase 1 · terminated
NCT04460937 — Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal an · Phase 1 · active not recruiting
NCT04590248 — A Study of Adavosertib as Treatment for Uterine Serous Carcinoma · Phase 2 · completed
NCT03284385 — Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2 · Phase 2 · active not recruiting

Other recruiting trials for Advanced Malignant Solid Neoplasm

Currently open trials in the same condition.

NCT07141407 — Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and T · NA · recruiting
NCT07189195 — TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory · Phase 1 · recruiting
NCT07174661 — Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid · NA · recruiting
NCT06223542 — Studying TAK-243 in Patients With Advanced Cancer · Phase 1 · recruiting
NCT06311214 — Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastati · Phase 2 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04197713 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 20 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04197713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing