Phase 1
N=43
A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer
Hormone Treatment-naïve Participants With Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02141659 ↗Enrolled (actual)
43
Serious AEs
14.0%
Results posted
Nov 2018
Primary outcome: Primary: Part A: Number of Participants With Dose-limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-385 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Takeda
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With Dose-limiting Toxicities (DLTs) |
0; 0; 0; 0 | — |
| PRIMARY Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) |
3; 2; 3; 2 | — |
| PRIMARY Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities |
1; 0; 0; 1; 0; 0 | — |
| PRIMARY Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters |
1; 1; 0; 0; 1; 0 | — |
| PRIMARY Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters |
1; 2; 0; 0; 1; 2 | — |
| PRIMARY Part B: Number of Participants Reporting One or More TEAE |
15; 15 | — |
| PRIMARY Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities |
1; 3; 1; 0; 1; 0 | — |
| PRIMARY Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters |
7; 4; 1; 0; 1; 0 | — |
| PRIMARY Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters |
4; 2; 5; 4; 2; 5 | — |
| SECONDARY Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 |
191.7; 198.0; 250.0; 254.0; 23.53; 94.40 | — |
| SECONDARY Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 |
679.7; 933.0; 761.7; 663.3; 199.0; 363.8 | — |
| SECONDARY Part A: Serum Testosterone Concentrations for TAK-385 |
5.440; 6.505; 6.317; 7.853; 0.603; 0.977 | — |
| SECONDARY Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) |
-89.77; -93.91 | — |
| SECONDARY Part B: Plasma Concentration of Unchanged TAK-385 |
0.000; 0.000; 72.89; 88.58; 6.406; 9.854 | — |
| SECONDARY Part B: Serum Testosterone Concentrations for TAK-385 |
6.367; 7.243; 0.975; 0.867; 0.384; 0.463 | — |
Summary
The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Participants judged by the investigator to have the capacity to understand the study and follow the study rules.
- Participants whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed.
- Japanese male participants 20 or more years of age at the time of informed consent.
- Participants who, if they have a female partner who could become pregnant, agree to practice appropriate means of contraception from the time of informed consent throughout the entire study treatment period and for 4 months after the last dose of study drug.
- Participants in stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks (28 days) prior to study treatment initiation.
- Participants with histologically or cytologically confirmed prostate cancer.
- Participants whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for participants who have undergone radical prostatectomy.
- Participants who are considered eligible for hormone therapy for prostate cancer.
- Participants who have not received hormone therapy (example, gonadotropin-releasing hormone [GnRH] agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
- Participants who have not undergone surgical castration.
- Participants with serum testosterone at screening greater than (>) 150 nanogram per deciliter (ng/dL).
- Participants meeting either of the following criteria for prostate-specific antigen (PSA) at screening. Untreated prostate cancer: PSA at screening > 4.0 nanogram per milliliter (ng/mL) Treated* prostate cancer: PSA at screening > 0.2 ng/mL.
- Participants who have undergone prostatectomy or either or both of high intensity focused ultrasound therapy or radiotherapy (excluding 125I-brachytherapy) prior to the start of this study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status [17] of 0 or 1.
- Body mass index (BMI) at screening greater than or equal to (>=) 18.0 kilogram per square meter (kg/m^2).
Exclusion Criteria
- Participants exhibiting symptoms judged related to prostate cancer by the investigator (example, bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy.
- Participants who have received 5-alpha reductase inhibitors (except for participants who have been treated for male-pattern alopecias).
- Participants who have received chemotherapy for prostate cancer (including estramustine).
- Participants who have received 125I-brachytherapy.
- Participants who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation.
- Participants who underwent prostatectomy within 16 weeks (112 days before study treatment initiation.
- Treatment with any investigational compound within the 4 weeks (28 days) prior to the first dose of study drug or ongoing participation in another experimental trial related to the treatment of prostate cancer.
- Diagnosis or treatment for another systemic malignancy within 2 years before study treatment initiation, or who had received a diagnosis of another malignancy before that and have evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ who have undergone complete resection will not be excluded from the study.
- Participants taking drugs with moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitory or inducing effects, or any medications, supplements, or food products with P-glycoprotein (P-gp) inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation.
- Participants who have received TAK-385 in a past clinical study.
- Participants for whom it would be difficult to collect blood from a peripheral vein.
- Participants with uncontr
Data sourced from ClinicalTrials.gov (NCT02141659). 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.