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Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

This study has been terminated.
(AstraZeneca sponsored trials of AZD8931 have been halted)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01579578
First received: April 13, 2012
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.


Condition Intervention Phase
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
 Drug: AZD8931
Drug: Placebo
Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Who Progress Following First Line Therapy and Are Ineligible for Treatment With Trastuzumab by HER2 Status (SAGE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assess of the relative efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by comparison of the change in tumour size. [ Time Frame: at 8 weeks from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess of the relative efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by assessment of progression-free survival (PFS) [ Time Frame: At approximately 1 year ] [ Designated as safety issue: No ]
  • Investigation of the efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by assessment of objective response rate (ORR) [ Time Frame: At approximately 1.5 year ] [ Designated as safety issue: No ]
  • Assess of the efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by assessment of the percentage of patients without progressive disease (i.e. patients with CR, PR or SD) at 8 weeks [ Time Frame: At approximately 1.5 year ] [ Designated as safety issue: No ]
  • Assess of the efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by assessment of overall survival (OS) [ Time Frame: At approximately 1.5 year ] [ Designated as safety issue: No ]
  • Comparison and assess of the safety and tolerability of AZD8931 plus paclitaxel compared with paclitaxel alone bycompaling of number of Adverse event and death, findings of laboratory, Physical and Ophathalmic Examination, ECG, and ECHO [ Time Frame: At approximately 1.5 year ] [ Designated as safety issue: Yes ]
  • Investigation of the pharmacokinetics (PK) of AZD8931 and AZD8931 O-desmethyl metabolite (i.e.plasma concentration, AUC, Cmax, tmax and metabolite parent ratio) [ Time Frame: At approximately 1.5 year ] [ Designated as safety issue: No ]
  • To explore the relationship between patient response to AZD8931 and the baseline (pre-treatment) tumour status of HER hetero/homo-dimer pairs. [ Time Frame: At appriximately 1.5 year ] [ Designated as safety issue: No ]
  • To explore the relationship between patient response to AZD8931 and the baseline (pre-treatment) tumour status of the HER2 and HER3 receptor. [ Time Frame: At appriximately 1.5 year ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8931
40 mg, oral dose twice daily
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off.
Placebo Comparator: 2 Drug: Placebo
Placebo, oral dose twice daily
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off.

Detailed Description:

A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 years or older (20 years or older in Japan)
  • Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
  • Suitable for paclitaxel therapy.
  • At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
  • Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2

Exclusion Criteria:

  • Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
  • Any prior taxane therapy (at any time from diagnosis of gastric cancer)
  • Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
  • Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
  • Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579578

Locations
Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kawasaki, Kanagawa, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Fukuoka, Japan
Korea, Republic of
Research Site
Seongnam, Gyeonggi-do, Korea, Republic of
Research Site
Jeonju, Jeollabuk-do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Serban Ghiorghiu, M. D. Scarborough General Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01579578     History of Changes
Other Study ID Numbers: D0102C00006
Study First Received: April 13, 2012
Last Updated: March 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan: Department of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Metastatic Gastric Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status

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

ClinicalTrials.gov processed this record on May 23, 2013