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Be Part of Research - Trial Details - A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
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A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Completed

Open to: ALL

Age: 18.0 - N/A

Sutton London London Northwood

Medical Conditions

Stomach Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 \[mFOLFOX6\]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2013 Jun 2015

Publications

"Bang YJ, Kang YK, Ng M, Chung HC, Wainberg ZA, Gendreau S, Chan WY, Xu N, Maslyar D, Meng R, Chau I, Ajani JA. A phase II, randomised study of mFOLFOX6 with or without the Akt inhibitor ipatasertib in patients with locally advanced or metastatic gastric or gastroesophageal junction cancer. Eur J Cancer. 2019 Feb;108:17-24. doi: 10.1016/j.ejca.2018.11.017. Epub 2018 Dec 25."; "30592991"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants will receive bolus and infusional 5-fluorouracil on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. The infusion times for infusional 5-fluorouracil may be determined per local and/or institutional standards and product labeling.

Intervention Arm Group : Ipatasertib + mFOLFOX6;Placebo + mFOLFOX6;

Intervention Type : DRUG
Intervention Description : Participants will receive ipatasertib, 600 milligrams (mg) orally once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.

Intervention Arm Group : Ipatasertib + mFOLFOX6;

Intervention Type : DRUG
Intervention Description : Participants will receive leucovorin or equivalent substitute orally, on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity.

Intervention Arm Group : Ipatasertib + mFOLFOX6;Placebo + mFOLFOX6;

Intervention Type : DRUG
Intervention Description : Participants will receive oxaliplatin via intravenous (IV) infusion on Day 1 of each 14-day cycle (part of mFOLFOX6 therapy). Oxaliplatin will be discontinued after completion of 8 cycles

Intervention Arm Group : Ipatasertib + mFOLFOX6;Placebo + mFOLFOX6;

Intervention Type : DRUG
Intervention Description : Participants will receive matching oral placebo capsules once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.

Intervention Arm Group : Placebo + mFOLFOX6;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden hospital
    Sutton
    SM2 5PT
  • Sarah Cannon Research Institute
    London
    W1G 6AD
  • Royal Marsden Hospital; Dept of Med-Onc
    London
    SW3 6JJ
  • Mount Vernon Hospital; Centre For Cancer Treatment
    Northwood
    HA6 2RN


The study is sponsored by Genentech, Inc.



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Read full details for Trial ID: NCT01896531
Last updated 18 February 2022

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