Clinical Trial: NCT03383692 - My Cancer Genome

NCT03383692

Description:

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet. DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Related Conditions:

Breast Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03383692

Trial Eligibility

Document

Title

Brief Title: Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Official Title: A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors

Clinical Trial IDs

ORG STUDY ID: DS8201-A-A104
SECONDARY ID: 173790
NCT ID: NCT03383692

Conditions

Neoplasm Metastasis

Interventions

Drug	Synonyms	Arms
DS-8201a		Cohort 1: DS-8201a + Ritonavir
Ritonavir	Norvir	Cohort 1: DS-8201a + Ritonavir
Itraconazole	Sporanox, Orungal	Cohort 2: DS-8201a + Itraconazole

Purpose

Detailed Description

      The expected time from the first subject's enrollment until the last subject's enrollment is
      approximately 8.5 months. The screening period is 28 days and each cycle of treatment is 21
      days.

      The data for the primary analysis will cutoff after all subjects have either discontinued the
      study or completed at least 3 cycles, whichever comes first. After the primary analysis, the
      main study will be closed and transition to the extension period.

      Depending on the preliminary results of Cohort 1, Sponsor may decide whether Cohort 2 will be
      opened or not.

      The number of treatment cycles is not fixed in this study. Subjects who continue to derive
      clinical benefit from the study drug in the absence of withdrawal of consent, progressive
      disease (PD), or unacceptable toxicity may continue the study drug.

Trial Arms

Name	Type	Description	Interventions
Cohort 1: DS-8201a + Ritonavir	Experimental	DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3	DS-8201a Ritonavir
Cohort 2: DS-8201a + Itraconazole	Experimental	DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Itraconazole BID on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3	DS-8201a Itraconazole

Eligibility Criteria

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic solid malignant tumor, with
             HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization
             (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate]
             that is refractory to or intolerable with at least one prior systemic chemotherapy
             regimen, or for which no standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a contraindication for receiving ritonavir or itraconazole according to the
             prescribing information

          -  Has a medical history of myocardial infarction within 6 months before enrollment or
             symptomatic congestive heart failure

Maximum Eligible Age:	N/A
Minimum Eligible Age:	20 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
Time Frame:	Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)
Safety Issue:
Description:	Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.

Secondary Outcome Measures

Measure:	Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Time Frame:	Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose
Safety Issue:
Description:	Best objective response (BOR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Completed response (CR) was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Measure:	Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Time Frame:	Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose
Safety Issue:
Description:	Objective response ratio (ORR) was defined as the proportion of participants who achieved CR and PR as assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Measure:	Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Time Frame:	Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose
Safety Issue:
Description:	Objective response rate (defined as participants who achieved CR and PR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. ORR with confirmation is Objective Response Rate applying a confirmed response of CR/PR in RECIST version 1.1.

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Daiichi Sankyo Co., Ltd.

Trial Keywords

Unresectable or metastatic solid malignant tumors
Solid malignant tumors
Oncology
HER2
Antibody drug conjugate
ADC

Last Updated

June 14, 2021

Clinical Trials /

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors