Phase 1 N=40 Treatment

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

Neoplasm Metastasis

Bottom Line

View on ClinicalTrials.gov: NCT03383692 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Jun 2021

Primary outcome: Primary: Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 — 133; 140; 121; 126 ug/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: DS-8201a (Drug); Ritonavir (Drug); Itraconazole (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1	133; 140; 121; 126	—
PRIMARY Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1	8.98; 8.95	—
PRIMARY Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1	650; 701; 754; 810; 723; 791	—
PRIMARY Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1	32.7; 35.0; 37.2; 39.2	—
PRIMARY Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2	139; 142; 119; 130	—
PRIMARY Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2	8.65; 8.93	—
PRIMARY Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2	644; 706; 710; 789; 707; 790	—
PRIMARY Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2	29.9; 32.4; 34.8; 37.7	—
SECONDARY Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors	0; 0; 9; 10; 8; 8	—
SECONDARY Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors	9; 10	—
SECONDARY Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors	8; 7	—

Summary

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03383692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.