Hormone Receptor Positive Malignant Neoplasm of BreastPhase 1NCT03088527
Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
A Phase 1 study testing RAD140 in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Stemline Therapeutics, Inc. at 5 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- RAD140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Oct 2017to 24 Sep 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive metastatic or locally advanced or metastatic breast cancer.
- Clinically confirmed as postmenopausal.
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.
Who cannot join
- HER2 positive patients by local laboratory testing.
- Triple negative breast cancer.
- Any chemotherapy within the 28 days prior to the first dose of study drug.
- Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
- Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
- Fulvestrant within 30 days prior to first dose of study drug.
Show all 13Show fewer
- Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
- Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
- Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed >10 years prior to enrollment and no evidence of active liver disease.
- Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
- Untreated or uncontrolled brain metastasis.
- Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.
- Pregnant and nursing females.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cancer Center Protocol Office
Boston, Massachusetts, 02114
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
Read the detailed description
This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
- Being tested
- RAD140
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD140Drug
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| RAD140 Part A and Part B | Experimental | Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140.
Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose. Receives: Drug: RAD140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Measured: First 28 days of treatment
Number of adverse events related to study treatment
Number of adverse events related to study treatment
Measured: Up to 30 days after end of treatment
Number participants with dose interruptions and dose adjustments
Number participants with dose interruptions and dose adjustments
Measured: Up to 30 days after end of treatment
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Measured: Day 1 and 15
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Measured: Day 1 and 15
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 and Day 15
Tumor response
Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.
Measured: Screening and every 8 weeks for up to 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start23 Oct 2017
- Primary completion28 Aug 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director, Clinical Operations, Study director, Radius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088527
- Sponsor's protocol ID
- RAD140-01-001
- Status last verified
- Aug 2022
- First submitted
- 28 Feb 2017
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03088527
- Acronym / sponsor ID
- RAD140-01-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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 purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
Detailed description
This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD140 Part A and Part B | Experimental | Drug: RAD140Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140. Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Progressive metastatic or locally advanced or metastatic breast cancer.
- Clinically confirmed as postmenopausal.
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.
Key exclusion criteria (13 listed)
- HER2 positive patients by local laboratory testing.
- Triple negative breast cancer.
- Any chemotherapy within the 28 days prior to the first dose of study drug.
- Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
- Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
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 |
|---|---|---|
| RAD140RAD140 will be supplied as formulated drug-in-capsules for oral administration. | Drug | RAD140 Part A and Part B |
Primary outcome
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Time frame: First 28 days of treatment
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Number of adverse events related to study treatment
Time frame: Up to 30 days after end of treatment
Number of adverse events related to study treatment
Number participants with dose interruptions and dose adjustments
Time frame: Up to 30 days after end of treatment
Number participants with dose interruptions and dose adjustments
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day 1 and 15
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 and 15
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 and Day 15
Tumor response
Time frame: Screening and every 8 weeks for up to 12 months of treatment
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 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Sr. Director, Clinical Operations study director
Radius
5 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 RAD140 in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Stemline Therapeutics, Inc. at 5 sites in United States.
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 3 inclusion and 13 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment (time frame: First 28 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2022.