Clinical Trials /

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread

NCT04014075

Description:

This study will find out if trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer. They must have HER2-positive gastric or gastro-esophageal junction (GEJ) cancer: - that cannot be removed surgically - that has moved to other parts of the body - that got worse during or after treatment that included trastuzumab The study will enroll about 72 participants at about 25 to 30 sites. Sites will be in North America, Australia, Israel, and the European Union. There might be other countries as well.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread
  • Official Title: A Phase 2, Open-label, Single-arm Trial of Trastuzumab Deruxtecan (DS 8201a) in HER2-positive, Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-containing Regimen

Clinical Trial IDs

  • ORG STUDY ID: DS8201-A-U205
  • SECONDARY ID: 2019-001512-34
  • NCT ID: NCT04014075

Conditions

  • Adenocarcinoma Gastric Stage IV With Metastases
  • Adenocarcinoma - GEJ

Interventions

DrugSynonymsArms
Trastuzumab deruxtecanDS-8201aAll participants

Purpose

This study will find out if trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer. They must have HER2-positive gastric or gastro-esophageal junction (GEJ) cancer: - that cannot be removed surgically - that has moved to other parts of the body - that got worse during or after treatment that included trastuzumab The study will enroll about 72 participants at about 25 to 30 sites. Sites will be in North America, Australia, Israel, and the European Union. There might be other countries as well.

Trial Arms

NameTypeDescriptionInterventions
All participantsExperimentalParticipants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
  • Trastuzumab deruxtecan

Eligibility Criteria

        Inclusion Criteria:

          -  Men or women ≥18 years old (local regulatory guidelines apply)

          -  Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable
             or metastatic, and that progressed during or after treatment regimen containing
             trastuzumab

          -  Has at least one measurable lesion per RECIST v1.1, as confirmed by independent
             central review

          -  If of reproductive potential, agrees to use a highly effective form of contraception
             or avoid intercourse during and upon completion of the study and for at least 4.5
             months after the last dose of study drug

          -  Has protocol-defined adequate cardiac, renal and hepatic function

        Exclusion Criteria:

          -  Has had anticancer therapy after first-line treatment regimen containing trastuzumab

          -  Has uncontrolled cardiovascular disease, including any of the following: history of
             myocardial infarction (MI) within 6 months of enrollment or symptomatic congestive
             heart failure (New York Heart Association Class II to IV), troponin levels consistent
             with MI as defined according to the manufacturer within 28 days prior to enrollment,
             history of unstable angina or serious cardiac arrhythmia requiring treatment, or
             corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based
             on screening triplicate 12-lead electrocardiogram (ECG)

          -  Has history of non-infectious interstitial lung disease (ILD) or pneumonitis that
             required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out
             at screening

          -  Has clinically significant corneal disease or any other condition or disease that, per
             protocol or in the opinion of the investigator, precludes participation

          -  Has pleural effusion, ascites, or pericardial effusion that requires drainage,
             peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)

          -  Has spinal cord compression or clinically active central nervous system metastases,
             defined as untreated and symptomatic or requiring therapy with corticosteroids or
             anticonvulsants to control associated symptoms (Note: participants with clinically
             inactive brain metastases may be included in the study as well as participants with
             treated brain metastases who are no longer symptomatic and no longer require treatment
             with corticosteroids or anticonvulsants.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR), Confirmed by Independent Central Review
Time Frame:within approximately 30 months
Safety Issue:
Description:ORR is defined as the percentage of participants with Best Response of Complete Response (CR) or Partial Response (CR), assessed by Independent Central Review using Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Measure:Progression-Free Survival (PFS), based on Independent Central Review using RECIST v1.1
Time Frame:within approximately 30 months
Safety Issue:
Description:PFS is defined as the time from enrollment until objective tumor progression or withdrawing from the study for other reasons, whichever occurs first.
Measure:PFS, based on Investigator Assessment
Time Frame:within approximately 30 months
Safety Issue:
Description:The time from enrollment until disease progression or withdrawing from the study for other reasons, whichever occurs first, as assessed by the Investigator
Measure:ORR, based on Investigator Assessment
Time Frame:within approximately 30 months
Safety Issue:
Description:The percentage of participants with Best Response of Complete Response (CR) or Partial Response (PR), assessed by the Investigator
Measure:Overall Survival (OS)
Time Frame:within approximately 30 months
Safety Issue:
Description:Overall survival is defined as the time from enrollment until death from any cause, and is measured in the intent-to-treat population.
Measure:Duration of Response (DoR)
Time Frame:within approximately 30 months
Safety Issue:
Description:DoR is defined as the length of time the Best Response of CR or PR continued

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo, Inc.

Trial Keywords

  • Human epidermal receptor 2 positive
  • Unresectable or metastatic
  • HER2
  • Prior treatment regimen included trastuzumab

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