Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

NCT01063517 | Completed Phase 2 Results

• 1 other identifier: D0810C00039
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Gastric Cancer

Keywords

Poly(ADP ribose); polymerase (PARP); Gastric cancer; olaparib; PARP inhibitor; ATM AZD2281; Ku0059436; Homologous Recombination deficiency (HRD); Recurrent gastric cancer; metastatic gastric cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) in the Overall Study Population

  PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.

  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

• Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]

  PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.

  Tumour assessments are 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

Secondary Outcomes (15)

• Overall Survival (OS) in the Overall Study Population

  Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months

• Overall Survival (OS) in ATM Negative Patients

  Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months

• Objective Response Rate (ORR) in the Overall Study Population

  Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months

• Objective Response Rate (ORR) in the ATM Negative Patients

  Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months

• Percentage Change in Tumour Size at Week 8 in the Overall Study Population

  Tumour scans done at Baseline and week 8

Study Arms (2)

1

EXPERIMENTAL

Olaparib + paclitaxel

Drug: olaparib; Drug: paclitaxel

2

ACTIVE COMPARATOR

paclitaxel + placebo

Drug: paclitaxel; Drug: Placebo

Interventions

olaparib DRUG

100mg BID oral tablet continuous

1

paclitaxel DRUG

iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle

Also known as: Taxol

1; 2

Placebo DRUG

100mg BID oral tablet to match olaparib tablet

2

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Goyang-si, 410-769, South Korea

Location

Research Site

Jeonnam, 519-763, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 110-744, South Korea

Location

Research Site

Seoul, 134-791, South Korea

Location

Research Site

Seoul, 137-701, South Korea

Location

Research Site

Taegu, 705-035, South Korea

Location

Related Publications (1)

• Chan 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 DERIVED

Related Links

• CSR\_Synopsis\_D0810C00039
• D0810C00039Protocol\_and\_Amendments\_redacted\_SECURE

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

olaparib; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Anitra Fielding
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

+44 1625 517178

Study Officials

• Jane Robertson, BSc, MBCHB, MD

  AstraZeneca

  STUDY DIRECTOR

• Yung-Jue Bang, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 2, 2010
• Primary Completion: May 11, 2012
• Study Completion: June 29, 2023
• Last Updated: July 20, 2023
• Results First Posted: April 30, 2015

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

KR (7)