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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer

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Trial Information

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)


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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Assess of the relative efficacy of AZD8931 plus paclitaxel compared with paclitaxel alone by comparison of the change in tumour size.

Outcome Time Frame:

at 8 weeks from randomization

Safety Issue:

No

Principal Investigator

Serban Ghiorghiu, M. D.

Investigator Role:

Study Director

Investigator Affiliation:

Scarborough General Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D0102C00006

NCT ID:

NCT01579578

Start Date:

April 2012

Completion Date:

March 2013

Related Keywords:

  • Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
  • Metastatic Gastric Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status
  • Esophageal Diseases
  • Stomach Neoplasms

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