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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: September 11, 2014
Last verified: September 2014
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [ Time Frame: Baseline and 8 weeks, accessed up to data cut off on 4 December 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [ Time Frame: Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012 ] [ Designated as safety issue: No ]
    Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).

  • The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [ Time Frame: Baseline and 8 weeks, accessed up to data cut off on 4 December 2012 ] [ Designated as safety issue: No ]
    The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)


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
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: NCT01579578

Locations
Germany
Research Site
Hamburg, Germany
Research Site
Köln, Germany
Japan
Research Site
Chuo-ku, Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kawasaki-shi, Japan
Research Site
Matsuyama-shi, Japan
Research Site
Sapporo-shi, Japan
Korea, Republic of
Research Site
Jeonju-si, Korea, Republic of
Research Site
Seongnam-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Valencia, Spain
Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Serban Ghiorghiu, M. D. Scarborough General Hospital
  More Information

Additional 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
Results First Received: March 20, 2014
Last Updated: September 11, 2014
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:
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 November 25, 2014