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Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Phase 3 trial testing Olaparib in Gastric Cancer in 525 participants. Completed in 27 March 2023.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 525 |
| Start date | 3 September 2013 |
| Primary completion | 4 April 2016 |
| Estimated completion | 27 March 2023 |
| Sites | 57 locations across China, Taiwan, Japan, South Korea |
AstraZeneca — full company profile →
Adults 18 to 99, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from the date of randomization until death due to any cause
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 82 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 62 |
Time from the date of randomization until death due to any cause
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 19 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 11 |
Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 47 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 29 |
Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 11 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 7 |
Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 44 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 28 |
Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 12 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 5 |
Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 160 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 177 |
Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 29 | |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 33 |
Time from randomization to the first onset of a confirmed objective tumour response
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 57.0 | 54.5 – 64.0 |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 57.0 | 56.0 – 111.5 |
Time from randomization to the first onset of a confirmed objective tumour response
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 57.5 | 57.0 – 113.0 |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 57.0 | 55.0 – 58.0 |
Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 166.0 | 89.0 – 218.0 |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 64.0 | 54.0 – 186.0 |
Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits
| Group | Value | 95% CI |
|---|---|---|
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 171.0 | 124.0 – 350.0 |
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 108.0 | 57.0 – 113.0 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Olaparib 100 mg Tablets bd… | Placebo Tablets bd + Pacli… |
|---|---|---|---|
| Bone marrow disorder | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Granulocytopenia | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Jaundice cholestatic | Hepatobiliary disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — |
| Cholangitis | Hepatobiliary disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Device related infection | Infections and infestations | — | — |
| Lung infection | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Reaction | System | Olaparib 100 mg Tablets bd… | Placebo Tablets bd + Pacli… |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Haemoglobin decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Hypoaesthesia | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Malaise | General disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Bone marrow disorder, Pneumonia, Febrile neutropenia, Granulocytopenia, Leukopenia, Abdominal pain, Ileus, Vomiting.
Data from ClinicalTrials.gov NCT01924533 adverse events section.
This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT01924533.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing