Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01924533
First received: August 14, 2013
Last updated: January 22, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Gastric Cancer
Drug: Olaparib
Drug: Paclitaxel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Scans taken 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 up to 3 years ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Scans taken 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 up to 3 years ] [ Designated as safety issue: No ]
  • To investigate plasma exposure to olaparib in a subset of olaparib dosed patients in the presence of paclitaxel and assess the impact of previous gastric surgery on that exposure [ Time Frame: Blood samples (2 mL) for determination of olaparib in plasma will be taken at the times on pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours after first dose of study ] [ Designated as safety issue: No ]
  • Time to 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 [ Time Frame: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Assessment of Adverse events (AEs) [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: Yes ]
  • Assessments of physical examination, vital signs (including blood pressure (BP) and pulse) [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: Yes ]
  • Assessment of electrocardiogram (ECG)(if clinically indicated) [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: Yes ]
  • Assessment of laboratory findings including clinical chemistry, haematology and urinalysis (if clinically indicated) [ Time Frame: Assessed up to 3 years ] [ Designated as safety issue: Yes ]
  • Time to response [ Time Frame: Scans taken 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 up to 3 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Scans taken 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 up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaparib+ paclitaxel
olaparib + paclitaxel
Drug: Olaparib
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.
Drug: Paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
Placebo Comparator: Placebo+paclitaxel
placebo+ paclitaxel
Drug: Paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
Drug: Placebo
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Detailed Description:
A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924533

Locations
China
Research Site
Beijing, China
Research Site
Bengbu, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Harbin, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Urumqi, China
Research Site
Wanzhou, China
Research Site
Wuhan, China
Research Site
Yangzhou, China
Research Site
Zhengzhou, China
Japan
Research Site
Chiba-shi, Japan
Research Site
Chuo-ku, Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kasama-shi, Japan
Research Site
Kawasaki-shi, Japan
Research Site
Kitaadachi-gun, Japan
Research Site
Koto-ku, Japan
Research Site
Matsuyama-shi, Japan
Research Site
Nagoya-shi, Japan
Research Site
Sapporo-shi, Japan
Research Site
Takatsuki-shi, Japan
Research Site
Utsunomiya-shi, Japan
Research Site
Yokohama-shi, Japan
Korea, Republic of
Research Site
Anyang-si, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Hwasun-gun, Korea, Republic of
Research Site
Jeonju-si, Korea, Republic of
Research Site
Seongnam-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Taiwan
Research Site
Kaohsiung Hsien, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Tao-Yuan, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yung-Jue Bang, MD Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01924533     History of Changes
Other Study ID Numbers: D081BC00004 
Study First Received: August 14, 2013
Last Updated: January 22, 2016
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Food and Drug Administration, Ministry of Health and Welfare

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on May 02, 2016