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NCT01896531 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
153
Enrollment target

NCT01896531 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 153 participants.

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The verdict

NCT01896531, a Phase 2 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
153 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Ipatasertib
  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG 5-Fluorouracil

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2013-08-14
Est. Completion 2021-01-26
Phase Phase 2

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01896531

The ClinicalTrials.gov registry entry for NCT01896531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01896531 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01896531 about?

NCT01896531 is a clinical study titled "A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer". 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...

What is the current status of trial NCT01896531?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2013-08-14. Estimated completion is 2021-01-26.

What interventions are being tested in trial NCT01896531?

The interventions under investigation include: Placebo (DRUG), Ipatasertib (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG).

Who is sponsoring clinical trial NCT01896531?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.