Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric Cancer



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:12/22/2018
Start Date:February 9, 2018
End Date:September 1, 2021
Contact:Jeannie Hou, Senior Director
Email:clinicaltrials@beigene.com
Phone:1 (877) 828-5568

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PARALLEL 303: A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

This study will enroll subjects with previously-treated advanced or inoperable gastric cancer
who have responded to first line platinum therapy into two treatment arms. In Arm A subjects
will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to
show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects
with advanced or inoperable gastric cancer.

This is a double-blind, placebo controlled, randomized multicenter global phase 3 study
comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP)
inhibitor BGB-290 to placebo as maintenance therapy in subjects with advanced gastric cancer
who have responded to first line platinum based chemotherapy. Subjects are randomized 1:1 to
BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker
status, and ECOG performance status.

Patients will undergo tumor assessments at screening and then every 8 weeks, or as clinically
indicated. Administration of BGB-290 or placebo will continue until disease progression,
unacceptable toxicity, death, or another discontinuation criterion is met.

After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks
for those patients without disease progression, survival status, and new anticancer therapy.

Inclusion Criteria:

1. Age ≥ 18 years.

2. Signed informed consent.

3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of
the stomach or gastroesophageal junction.

4. Received platinum based first line chemotherapy for ≤ 28 weeks.

5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

7. ECOG performance status ≤ 1.

8. Adequate hematologic, renal and hepatic function.

9. Must be able to provide archival tumor tissue for central biomarker assessment.

10. Females of childbearing potential and non-sterile males must agree to use highly
effective methods of birth control throughout the course of study and at least up to 6
months after last dosing.

Exclusion Criteria:

1. Unresolved acute effects of prior therapy ≥ Grade 2.

2. Prior treatment with PARP inhibitor.

3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days
prior to randomization.

4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

5. Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.

6. Other diagnoses of significant malignancy

7. Leptomeningeal disease or brain metastasis

8. Inability to swallow capsules or disease affecting gastrointestinal function.

9. Active infections requiring systemic treatment.

10. Clinically significant cardiovascular disease

11. Pregnant or nursing females.
We found this trial at
14
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Charlotte, NC
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Gosford, New South Wales
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Goshen, Indiana 46526
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Louisville, Kentucky 40207
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Nashville, Tennessee 37232
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Portland, OR
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Santa Rosa, California 95403
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The Woodlands, Texas 77380
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The Woodlands, TX
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West Palm Beach, Florida 33401
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Wichita, KS
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