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

NCT01579578 | Terminated Phase 2 Results

• 1 other identifier: D0102C00006
• Study Type: interventional
• Target: 39
• Locations: 5 countries
• Sites: 15

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.

Conditions

Metastatic, Gastric or Gastro-oesophageal Junction, Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

  Baseline and 8 weeks, accessed up to data cut off on 4 December 2012

Secondary Outcomes (2)

• Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

  Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012

• The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

  Baseline and 8 weeks, accessed up to data cut off on 4 December 2012

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD8931; Drug: Paclitaxel

2

PLACEBO COMPARATOR

Drug: Placebo; Drug: Paclitaxel

Interventions

AZD8931 DRUG

40 mg, oral dose twice daily

1

Placebo DRUG

Placebo, oral dose twice daily

2

Paclitaxel DRUG

IV once weekly for 3 weeks followed by a week off.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Cologne, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Chūōku, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Kawasaki-shi, Japan

Location

Research Site

Matsuyama, Japan

Location

Research Site

Sapporo, Japan

Location

Research Site

Jeonju, South Korea

Location

Research Site

Seongnam-si, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Barcelona, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Taichung, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Related Links

• D0102C00006\_CSR\_Synopsis

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

AZD 8931; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr Serban Ghiorghiu
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Serban Ghiorghiu, M. D.

  Scarborough General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 18, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

DE (2); JP (5); TW (2); ES (3); KR (3)