A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | August 31, 2013 |
| End Date: | June 30, 2019 |
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
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy of GDC-0068 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 GDC-0068 or placebo orally daily on Days 1 to 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 (up to approximately 2 years).
efficacy of GDC-0068 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 GDC-0068 or placebo orally daily on Days 1 to 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 (up to approximately 2 years).
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically documented, inoperable locally advanced or metastatic or recurrent
gastric/GEJ adenocarcinoma, not amenable to curative therapy
- Measurable disease, according to RECIST v1.1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and organ function
Exclusion Criteria:
- Previous chemotherapy for inoperable locally advanced or metastatic gastric/GEJ
adenocarcinoma. Participants 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 human epidermal growth factor receptor 2 (HER2)-positive gastric/GEJ
adenocarcinoma
- Radiation treatment within 28 days of randomization. Participants who have received
palliative radiation treatment to peripheral sites (eg, 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, phosphatidylinositol
3-kinase (PI3K), and/or mammalian target of rapamycin (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 procedure during
the course of the study
We found this trial at
9
sites
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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