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

• ClinicalTrials.gov Identifier: NCT03427814
• Recruitment Status: Recruiting
• First Posted: February 9, 2018
• Last Update Posted: November 4, 2019
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Advanced or Inoperable Gastric Cancer	Drug: BGB-290; Drug: Placebo	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: July 23, 2018
• Estimated Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: September 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A; Approximately 270 subjects to receive BGB-290 orally.	Drug: BGB-290; 60 mg PO BID; Other Name: pamiparib
Placebo Comparator: Arm B; Approximately 270 subjects to receive placebo orally.	Drug: Placebo; 60 mg PO BID

Outcome Measures

Primary Outcome Measures :

1. Progression free survival [ Time Frame: From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first up to 5 years ]
   The primary objective of this study is to compare progression free survival between treatment groups (BGB-290 versus placebo) as determined by blinded independent central review.

Secondary Outcome Measures :

1. Overall survival between treatment groups (BGB-290 versus placebo) [ Time Frame: From time of randomization until date of death due to any cause assessed, up to 5 years ]
2. Progression free survival between treatment groups determined by investigator assessment [ Time Frame: From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first, up to 5 years ]
3. Progression free survival on subsequent treatment (PFS2) [ Time Frame: From the time of randomization to second disease progression, or death from any cause, whichever is first, up to 5 years ]
4. Time to second subsequent treatment [ Time Frame: From the time from randomization until the second subsequent anti-cancer therapy or death after next-line therapy, up to 5 years ]
5. Objective response rate by investigator assessment [ Time Frame: From randomization to first documentation of disease progression assessed up to 5 years ]
6. Duration of response by investigator assessment [ Time Frame: The time from the first documented confirmed response of CR or PR to PD or death due to any cause, whichever occurs first, up to 5 years ]
7. Time to response by investigator assessment [ Time Frame: Defined as the time from randomization to the first documented confirmed response of CR or PR assessed up to 5 years ]
8. Incidence, nature and severity of adverse events between treatment groups [ Time Frame: From time of randomization to approximately 30 days after end of treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: BeiGene; 1 (877) 828-5568; clinicaltrials@beigene.com

  Show 99 Study Locations

Sponsors and Collaborators

BeiGene

Investigators

• Study Director: Heinrich Farin, MD; BeiGene

More Information

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT03427814 History of Changes
• Other Study ID Numbers: BGB-290-303; 2017-003493-13 ( EudraCT Number ); CTR20171664 ( Registry Identifier: Center for drug evaluation, CFDA )
• First Posted: February 9, 2018
• Last Update Posted: November 4, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:

BGB-290; PARP inhibitor; Phase 3; maintenance therapy; gastric cancer; oral treatment; PARALLEL303; PARALLEL 303; PARALLEL; BGB290303; BGB-290-303

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases