Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
CompletedPhase 2Results postedLast updated 11 December 2024
What this trial tests
Phase 2 trial testing Olaparib in Advanced Malignant Solid Neoplasm in 6 participants. Completed in 30 June 2024.
Adults 12 Months to 21, any sex, with Advanced Malignant Solid Neoplasm or Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma. 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.
Objective Response Rate (Complete Response/Partial Response)Primary· Up to 2 years from study entry
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
Group
Value
95% CI
Treatment (Olaparib)
0
0 – 0
Progression Free Survival (PFS)Secondary· Up to 6 months from study entry
The Kaplan-Meier method will be used to estimate the 6 month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
Group
Value
95% CI
Treatment (Olaparib)
33.3
4.6 – 67.6
Percentage of Patients Experiencing Treatment-related Grade 3 or Higher Adverse EventsSecondary· Up to 2 years from study entry
Percentage of patients experiencing treatment-related grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Group
Value
95% CI
Treatment (Olaparib)
16.7
0.4 – 64.1
Pharmacokinetics (PK) of Olaparib, Area Under the Curve (AUC)Secondary· Up to day 8 of cycle 1
The mean (sd) of the AUC.
Group
Value
95% CI
Treatment (Olaparib)
48.8
± 27.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Olaparib)
Serious: 3/6 (50%)
Deaths: 4/6
Serious adverse events (4 terms)
Reaction
System
Treatment (Olaparib)
Disease progression
General disorders
—
Allergic reaction
Immune system disorders
—
Hypercalcemia
Metabolism and nutrition disorders
—
Seizure
Nervous system disorders
—
Other adverse events (47 terms — click to expand)
Reaction
System
Treatment (Olaparib)
Lymphocyte count decreased
Investigations
—
Anemia
Blood and lymphatic system disorders
—
Nausea
Gastrointestinal disorders
—
White blood cell decreased
Investigations
—
Vomiting
Gastrointestinal disorders
—
Dizziness
Nervous system disorders
—
Headache
Nervous system disorders
—
Hypertension
Vascular disorders
—
Cardiac disorders - Other, specify
Cardiac disorders
—
Sinus tachycardia
Cardiac disorders
—
Eye pain
Eye disorders
—
Optic nerve disorder
Eye disorders
—
Abdominal pain
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
Dyspepsia
Gastrointestinal disorders
—
Edema limbs
General disorders
—
Fatigue
General disorders
—
Gait disturbance
General disorders
—
General disorders and administration site conditions - Other, specify
This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body (advanced) and have come back (relapsed) or do not respond to treatment (refractory). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
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NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che
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NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo
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Currently open trials in the same condition.
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Trials by the same sponsor.
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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: 11 December 2024
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/NCT03233204.