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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01924533
First received: August 14, 2013
Last updated: August 27, 2014
Last verified: August 2014
  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: 629
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 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 and older
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

Contacts
Contact: Xiaojin Shi +86 21 60302409 ClinicalTrialTransparency@astrazeneca.com

Locations
China
Research Site Not yet recruiting
Hangzhou, China
Research Site Not yet recruiting
Nanjing, China
Research Site Not yet recruiting
Shanghai, China
Japan
Research Site Recruiting
Chiba-shi, Japan
Research Site Recruiting
Chuo-ku, Japan
Research Site Recruiting
Fukuoka-shi, Japan
Research Site Recruiting
Kasama-shi, Japan
Research Site Withdrawn
Kashiwa-shi, Japan
Research Site Recruiting
Kawasaki-shi, Japan
Research Site Recruiting
Koto-ku, Japan
Research Site Recruiting
Matsuyama-shi, Japan
Research Site Recruiting
Nagoya-shi, Japan
Research Site Recruiting
Sapporo-shi, Japan
Research Site Recruiting
Takatsuki-shi, Japan
Research Site Recruiting
Utsunomiya-shi, Japan
Research Site Recruiting
Yokohama-shi, Japan
Korea, Republic of
Research Site Recruiting
Anyang-si, Korea, Republic of
Research Site Recruiting
Daegu, Korea, Republic of
Research Site Recruiting
Hwasun-gun, Korea, Republic of
Research Site Recruiting
Jeonju-si, Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Taiwan
Research Site Not yet recruiting
Kaohsiung Hsien, Taiwan
Research Site Recruiting
Taichung, Taiwan
Research Site Not yet recruiting
Tainan, Taiwan
Research Site Not yet recruiting
Taipei, Taiwan
Research Site Not yet recruiting
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01924533     History of Changes
Other Study ID Numbers: D081BC00004
Study First Received: August 14, 2013
Last Updated: August 27, 2014
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
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014