A Phase 1 interventional study of DS-8201a and Ritonavir in Neoplasm Metastasis, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 10 sites in 3 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Daiichi Sankyo Co., Ltd. · Phase 1, Interventional, and Treatment
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).
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Daiichi Sankyo Co., Ltd. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: DS-8201a · Drug: Ritonavir
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
Drug: DS-8201a · Drug: Itraconazole
DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
Also known as: Norvir
Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
Also known as: Sporanox, Orungal
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.
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)
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
Maximum concentration (Cmax) was assessed for MAAA-1181a.
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)
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) for DS-8201a and total anti-HER2 antibody were assessed.
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)
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.
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)
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2
Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.
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)
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
Maximum concentration (Cmax) was assessed for MAAA-1181a.
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)
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for DS-8201a and total anti-HER2 antibody.
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)
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.
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)
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
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.
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
Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
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.
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
Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
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.
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
A total of 40 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 10 study centers in Japan, South Korea, and Taiwan.
| Milestone | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| Started | 17 | 23 |
| Completed | 11 | 19 |
| Not completed | 6 | 4 |
| Withdrew: Progressive disease as per recist | 3 | 3 |
| Withdrew: Clinical progression | 0 | 1 |
| Withdrew: Adverse event | 3 | 0 |
Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.
| ug/mL | Cohort 1: DS-8201a + Ritonavir |
|---|---|
| DS-8201a, Cycle 2: DS-8201a only | 133 ± 25.5 |
| DS-8201a, Cycle 3: DS-8201a + ritonavir | 140 ± 23.0 |
| Total Anti-HER2 antibody, Cycle 2: DS-8201a only | 121 ± 22.2 |
| Total Anti-HER2 antibody, Cycle 3: DS-8201a + ritonavir | 126 ± 23.1 |
Maximum concentration (Cmax) was assessed for MAAA-1181a.
| ng/mL | Cohort 1: DS-8201a + Ritonavir |
|---|---|
| MAAA-1181a, Cycle 2: DS-8201a only | 8.98 ± 2.83 |
| MAAA-1181a, Cycle 3: DS-8201a + ritonavir | 8.95 ± 3.68 |
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) for DS-8201a and total anti-HER2 antibody were assessed.
| ug*d/mL | Cohort 1: DS-8201a + Ritonavir |
|---|---|
| DS-8201a, Cycle 2 (DS-8201a only): AUC17d | 650 ± 168.0 |
| DS-8201a, Cycle 2 (DS-8201a only): AUCtau | 701 ± 185 |
| DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUC17d | 754 ± 137.0 |
| DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUCtau | 810 ± 153.0 |
| Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUC17d | 723 ± 191 |
| Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUCtau | 791 ± 217 |
| Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUC17d | 796 ± 155 |
| Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUCtau | 860 ± 170 |
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.
| ng*d/mL | Cohort 1: DS-8201a + Ritonavir |
|---|---|
| MAAA-1181a, Cycle 2 (DS-8201a only): AUC17d | 32.7 ± 7.45 |
| MAAA-1181a, Cycle 2 (DS-8201a only): AUCtau | 35.0 ± 8.10 |
| MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUC17d | 37.2 ± 6.93 |
| MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUCtau | 39.2 ± 7.98 |
Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.
| ug/mL | Cohort 1: DS-8201a + Itraconazole |
|---|---|
| DS-8201a, Cycle 2: DS-8201a only | 139 ± 23.6 |
| DS-8201a, Cycle 3: DS-8201a + ritonavir | 142 ± 23.9 |
| Total Anti-HER2 antibody, Cycle 2: DS-8201a only | 119 ± 19.1 |
| Total Anti-HER2 antibody, Cycle 3: DS-8201a + ritonavir | 130 ± 18.2 |
Maximum concentration (Cmax) was assessed for MAAA-1181a.
| ng/mL | Cohort 2: DS-8201a + Itraconazole |
|---|---|
| MAAA-1181a, Cycle 2: DS-8201a only | 8.65 ± 2.03 |
| MAAA-1181a, Cycle 3: DS-8201a + ritonavir | 8.93 ± 1.77 |
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for DS-8201a and total anti-HER2 antibody.
| ug*d/mL | Cohort 2: DS-8201a + Itraconazole |
|---|---|
| DS-8201a, Cycle 2 (DS-8201a only): AUC17d | 644 ± 188 |
| DS-8201a, Cycle 2 (DS-8201a only): AUCtau | 706 ± 211 |
| DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUC17d | 710 ± 187 |
| DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUCtau | 789 ± 217 |
| Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUC17d | 707 ± 194 |
| Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUCtau | 790 ± 224 |
| Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUC17d | 781 ± 196 |
| Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUCtau | 883 ± 238 |
Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.
| ng*d/mL | Cohort 2: DS-8201a + Itraconazole |
|---|---|
| MAAA-1181a, Cycle 2 (DS-8201a only): AUC17d | 29.9 ± 8.31 |
| MAAA-1181a, Cycle 2 (DS-8201a only): AUCtau | 32.4 ± 9.21 |
| MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUC17d | 34.8 ± 8.04 |
| MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUCtau | 37.7 ± 8.87 |
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.
| Participants | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| Complete response (CR) | 0 | 0 |
| Partial response (PR) | 9 | 10 |
| Stable disease (SD) | 8 | 8 |
| Non-CR/Non-PR | 0 | 0 |
| Progressive disease (PD) | 0 | 1 |
| Non evaluable | 0 | 0 |
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.
| Participants | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | 9 | 10 |
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.
| Participants | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | 8 | 7 |
Collected over Adverse event data were collected from baseline up to approximately 9 months post-dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: DS-8201a + Ritonavir | 1/17 (5.9%) | 2/17 (11.8%) | 17/17 (100%) |
| Cohort 2: DS-8201a + Itraconazole | 0/23 (0%) | 3/23 (13%) | 22/23 (95.7%) |
| Event | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| Disease progressionGeneral disorders | 1/17 | 0/23 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/17 | 0/23 |
| PyrexiaGeneral disorders | 0/17 | 1/23 |
| DiarrhoeaGastrointestinal disorders | 0/17 | 1/23 |
| IleusGastrointestinal disorders | 0/17 | 1/23 |
| NauseaGastrointestinal disorders | 0/17 | 1/23 |
| VomitingGastrointestinal disorders | 0/17 | 1/23 |
| SepsisInfections and infestations | 0/17 | 1/23 |
| Event | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole |
|---|---|---|
| NauseaGastrointestinal disorders | 17/17 | 15/23 |
| Decreased appetiteMetabolism and nutrition disorders | 13/17 | 9/23 |
| Platelet count decreasedInvestigations | 9/17 | 4/23 |
| ConstipationGastrointestinal disorders | 8/17 | 7/23 |
| DiarrhoeaGastrointestinal disorders | 8/17 | 5/23 |
| White blood cell count decreasedInvestigations | 7/17 | 7/23 |
| Alanine aminotransferase increasedInvestigations | 7/17 | 3/23 |
| AnaemiaBlood and lymphatic system disorders | 6/17 | 5/23 |
| AlopeciaSkin and subcutaneous tissue disorders | 6/17 | 7/23 |
| Neutrophil count decreasedInvestigations | 6/17 | 8/23 |
Demographics were assessed in the Safety Analysis Set.
| Age, Continuous(years) | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole | Total |
|---|---|---|---|
| Mean | 60.5 ± 9.45 | 53.5 ± 12.91 | 56.5 ± 11.96 |
| Age, Customized(Participants) | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole | Total |
|---|---|---|---|
| <65 years | 10 | 18 | 28 |
| ≥65 years | 7 | 5 | 12 |
| Sex: Female, Male(Participants) | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 5 | 13 | 18 |
| Race (NIH/OMB)(Participants) | Cohort 1: DS-8201a + Ritonavir | Cohort 2: DS-8201a + Itraconazole | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 17 | 23 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from Jan 2018 to primary completion in Sep 2018, 8 months.
Results were first posted in Jun 2021, 2 years 8 months after primary completion.
Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's 8 months is below that.
Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab deruxtecan