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CompletedNCT02623751Updated Jun 21, 2022

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

A Phase 1 interventional study of KHK2375 and Exemestane in Breast Cancer, sponsored by Kyowa Kirin Co., Ltd.. Completed at 3 sites in Japan. Open to female participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
20 Years to 74 Years
Sex
Female
01

Study summary

The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 15 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.

Browse Kyowa Kirin Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Postmenopausal women aged ≥ 20 and \< 75 years at the time of consent;
  • Estrogen receptor positive and/or progesterone receptors positive;
  • HER2-negative
  • Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane

Exclusion criteria

Exclusion Criteria:

  • Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;
  • Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;
  • Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;
  • Ongoing treatment with other investigational product
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    KHK2375 PO and Exemestane PO

    KHK2375 and Exemestane

    Drug: KHK2375 · Drug: Exemestane

Interventions

  • DrugKHK2375

    KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.

  • DrugExemestane

    KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.

    Also known as: Entinostat, MS-275, SDNX-275

06

What researchers measure

Primary outcomes

  1. Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events

    Time frame: Assessed up to 28 days after study discontinuation

Secondary outcomes

  1. Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]

    Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1

  2. Pharmacokinetics of KHK2375 [Area under the curve (AUC)]

    Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1

  3. Pharmacokinetics of KHK2375 [Half-life (t1/2)]

    Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1

07

Study locations

3 sites
  • Chikusa-ku, Aichi-ken, Japan
  • Chuo-ku, Osaka, Japan
  • Chuo-ku, Tokyo, Japan
08

References and documents

Publications

  • Masuda N, Tamura K, Yasojima H, Shimomura A, Sawaki M, Lee MJ, Yuno A, Trepel J, Kimura R, Nishimura Y, Saji S, Iwata H. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer. BMC Cancer. 2021 Nov 24;21(1):1269. doi: 10.1186/s12885-021-08973-4. PubMed 34819039 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Oct 2020, 59 months.

Of 306 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's 59 months is above that.

Counting every sponsor, half of 645 studies reached it within 45 months; a quarter within 25 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2015
First posted
Dec 8, 2015
StartActual
Nov 2015
Primary completionActual
Oct 2020
CompletionActual
Oct 2020
Last update
Jun 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02623751
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Dec 8, 2015
Start date
Nov 2015
Primary completion
Oct 2020
Completion
Oct 2020
Last update
Jun 21, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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