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

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ClinicalTrials.gov Identifier: NCT01579578
Recruitment Status : Terminated (AstraZeneca sponsored trials of AZD8931 have been halted)
First Posted : April 18, 2012
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Drug: AZD8931 Drug: Placebo Drug: Paclitaxel Phase 2

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : April 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01579578     History of Changes
Other Study ID Numbers: D0102C00006
First Posted: April 18, 2012    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014
Last Verified: September 2014

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
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action