Phase 2
Completed N=124
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
Source: ClinicalTrials.gov NCT01063517 ↗Enrolled (actual)
124
Serious AEs
32.5%
Results posted
Apr 2015
Primary outcomePrimary: Progression Free Survival (PFS) in the Overall Study Population — 3.91; 3.55 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) in the Overall Study Population |
3.91; 3.55 | — |
| PRIMARY Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] |
5.29; 3.68 | — |
| SECONDARY Overall Survival (OS) in the Overall Study Population |
13.1; 8.3 | — |
| SECONDARY Overall Survival (OS) in ATM Negative Patients |
NA; 8.20 | — |
| SECONDARY Objective Response Rate (ORR) in the Overall Study Population |
14; 9 | — |
| SECONDARY Objective Response Rate (ORR) in the ATM Negative Patients |
9; 6 | — |
| SECONDARY Percentage Change in Tumour Size at Week 8 in the Overall Study Population |
-5.8; 2.2 | — |
| SECONDARY Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients |
-6.9; -5.9 | — |
| SECONDARY Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population |
3.6; 2.8 | — |
| SECONDARY Time to Deterioration in QoL Fatigue Score in the Overall Study Population |
1.9; 1.8 | — |
| SECONDARY Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population |
3.7; 3.7 | — |
| SECONDARY Time to Deterioration in QoL Pain Domain Score in the Overall Study Population |
3.2; 3.1 | — |
| SECONDARY Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population |
3.7; 1.9 | — |
| SECONDARY Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population |
4.6; 5.1 | — |
| SECONDARY Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population |
6.9; 5.7 | — |
| SECONDARY Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population |
4.3; 2.8 | — |
| SECONDARY Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population |
2.8; 1.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01063517). 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.