Phase 3
Completed N=525
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Source: ClinicalTrials.gov NCT01924533 ↗Enrolled (actual)
525
Serious AEs
30.1%
Results posted
Nov 2018
Primary outcomePrimary: Overall Survival — 82; 62 participants — p=0.0262
◆ Published Evidence
Highly cited
291citations · ~32 / year
Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial.
Summary
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.
Linked Publications
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Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
19; 11 | 0.2458 |
| SECONDARY Progression-Free Survival (PFS) |
11; 7 | 0.2199 |
| SECONDARY Number of Patients With Objective Response. |
44; 28 | 0.0548 |
| SECONDARY Number of Patients Objective Response |
12; 5 | 0.0309 sig |
| SECONDARY Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale |
29; 33 | 0.0927 |
| SECONDARY Time to Response |
57.5; 57.0 | — |
| SECONDARY Duration of Response |
171.0; 108.0 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced gastric cancer (including GEJ) that has progressed following first-line therapy.
- Patients must be ≥18 years of age. Age ≥20 if Japanese
- Provision of tumour sample (from either a resection or biopsy).
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and following up visits.
Exclusion Criteria
- More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)] polymerisation (PARP) inhibitor, including olaparib.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.
- Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.
Data sourced from ClinicalTrials.gov (NCT01924533) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.