1 von 5 11.12.2013 09:04 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GO28341 Previous Study Return to List Next Study A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer This study is currently recruiting participants. Verified December 2013 by Sponsor: Information provided by (Responsible Party): ClinicalTrials.gov Identifier: NCT01896531 First received: July 8, 2013 Last updated: December 2, 2013 Last verified: December 2013 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of GDC-0068 in combination with mfolfox6 chemotherapy in patients with advanced or metastatic gastric or gastroesophageal junction cancer. Patients will be randomized to receive either GDC-0068 or placebo orally daily on Days 1-7 of each 14-day cycle in combination with mfolfox6 on Day 1 of each cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Condition Intervention Phase Gastric Cancer Drug: GDC-0068 Drug: Placebo Phase 2
Study Type: Study Design: Official Title: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment A Randomized, Phase II, Placebo Controlled Study of GDC-0068, an Inhibitor to Akt, in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Resource links provided by NLM: MedlinePlus related topics: Cancer Stomach Cancer Drug Information available for: Oxaliplatin U.S. FDA Resources Further study details as provided by : Primary Outcome Measures: Progression-free survival (RECIST v1.1 criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ] Secondary Outcome Measures: Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ] Confirmed objective tumor response in patients with measurable soft tissue disease at baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ] Duration of confirmed objective response in patients with measurable soft tissue disease at baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ] Estimated Enrollment: 120 Study Start Date: August 2013 Estimated Study Completion Date: August 2015 Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure) Arms Assigned Interventions 2 von 5 11.12.2013 09:04
Experimental: GDC-0068 + mfolfox6 Drug: GDC-0068 Orally daily Days 1-7 of each 14-day cycle Modified FOLFOX6 i.v. on Day 1 of each cycle Active Comparator: Placebo + mfolfox6 Drug: Placebo Orally daily Days 1-7 of each 14-day cycle Modified FOLFOX6 i.v. on Day 1 of each cycle Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No Criteria Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Histologically documented, inoperable locally advanced or metastatic or recurrent gastric/gej (gastroesophageal junction) adenocarcinoma, not amenable to curative therapy Measurable disease, according to RECIST v1.1 Life expectancy >/= 12 weeks Adequate hematologic and organ function Exclusion Criteria: Previous chemotherapy for inoperable locally advanced or metastatic gastric/gej adenocarcinoma. Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced gastric/gej adenocarcinoma, provided all treatments were completed >/= 6 months prior to randomization. Known HER2-positive gastric/gej adenocarcinoma. Radiation treatment within 28 days of randomization. Patients who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) within 28 days of randomization may be enrolled in the study if they have recovered from all acute, reversible effects and with notification of the Medical Monitor. Previous therapy for gastric/gej adenocarcinoma with Akt, PI3K, and/or mtor inhibitors Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical 3 von 5 11.12.2013 09:04
procedure during the course of the study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01896531 Contacts Contact: Reference Study ID Number: GO28341 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com Show 51 Study Locations Sponsors and Collaborators Investigators Study Director: Clinical Trials More Information No publications provided Responsible Party: ClinicalTrials.gov Identifier: NCT01896531 History of Changes Other Study ID Numbers: GO28341, 2012-002080-10 Study First Received: July 8, 2013 Last Updated: December 2, 2013 Health Authority: United States: Food and Drug Administration Additional relevant MeSH terms: Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions ClinicalTrials.gov processed this record on December 09, 2013 4 von 5 11.12.2013 09:04
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