Breast CancerPhase 1NCT02623751
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
A Phase 1 study testing KHK2375 and Exemestane in people with Breast Cancer, run by Kyowa Kirin Co., Ltd. at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- KHK2375 and Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesJapan
- Study dates
- Nov 2015to Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Chikusa-ku, Aichi-ken
Study site
Chuo-ku, Osaka
Study site
Chuo-ku, Tokyo
About this study
Official title: Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- KHK2375, Exemestane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK2375Drug
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.
ExemestaneDrug
Also called Entinostat, MS-275, SDNX-275
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.
| Study group | Role | What they receive |
|---|---|---|
| KHK2375 PO and Exemestane PO | Experimental | KHK2375 and Exemestane Receives: Drug: KHK2375; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
Measured: Assessed up to 28 days after study discontinuation
Secondary outcomes (3)
Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]
Measured: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Pharmacokinetics of KHK2375 [Area under the curve (AUC)]
Measured: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Pharmacokinetics of KHK2375 [Half-life (t1/2)]
Measured: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623751
- Sponsor's protocol ID
- 2375-001
- Status last verified
- Jun 2022
- First submitted
- 18 Nov 2015
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT02623751
- Acronym / sponsor ID
- 2375-001
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHK2375 PO and Exemestane PO | Experimental | Drug: KHK2375, Drug: ExemestaneKHK2375 and Exemestane |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHK2375KHK2375 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. | Drug | KHK2375 PO and Exemestane PO |
| ExemestaneAlso: Entinostat, MS-275, SDNX-275KHK2375 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. | Drug | KHK2375 PO and Exemestane PO |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 34819039Masuda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KHK2375 and Exemestane in people with Breast Cancer, run by Kyowa Kirin Co., Ltd. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.