Clinical trial · Interventional
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
NCT01063517CI-TRIAL-00068119completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| olaparib | Drug | Olaparib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Olaparib + paclitaxel
- interventionNames
- Drug: olaparib
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- paclitaxel + placebo
- interventionNames
- Drug: paclitaxel
- Drug: Placebo
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) in the Overall Study Population
- timeFrame
- Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or metastatic gastric cancer that has progressed following first line-therapy * Confirmed ATM protein status by IHC archival tumour sample * At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits Exclusion Criteria: * More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting * Any previous treatment with a 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
References
Publications (1)
- DERIVEDChan KH, Rutazanaa D, Wray C, Thosani N, Yang V, Cen P. Promising Response of Olaparib in Patient With Germline ATM-Mutated Metastatic Gastric Cancer. J Investig Med High Impact Case Rep. 2024 Jan-Dec;12:23247096241240176. doi: 10.1177/23247096241240176. PMID 38504422