Triple Negative Breast CancerPhase 2NCT03733119
ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer
A Phase 2 study testing Akt/ERK Inhibitor ONC201 and Methionine-Restricted Diet in people with Triple Negative Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Akt/ERK Inhibitor ONC201 and Methionine-Restricted Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to 13 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic or unresectable TNBC (estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10% and HER2 negative either by immunohistochemistry [IHC] or in situ hybridization method by American Society of Clinical Oncology [ASCO]-College of American Pathologists [CAP] guidelines). For patients with a previous tumor sample with positive ER, PR and/or HER2 results, if the most recent biopsy meets study criteria, they will be eligible.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. within 28 days prior to registration
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- Any number of prior lines of systemic therapy for metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Prior cancer treatment, including radiotherapy, must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen to =< grade 1 or to baseline prior to initiation of that therapy. Grade 2 or higher exceptions include alopecia, up to grade 2 neuropathy, and other grade 2 AEs or lab values not constituting a safety risk in the opinion of the treating physician. This criteria does not apply to lab tests for normal organ and marrow function outlined below.
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- No active central nervous system (CNS) metastatic disease; subjects with prior definitive treatment of their CNS disease by surgical resection, stereotactic body radiation therapy (SBRT) or whole-brain radiotherapy (WBRT) > 28 days ago will be eligible if asymptomatic and off systemic steroids
- Life expectancy of greater than 12 weeks
- Normal organ and marrow function as defined per protocol definitions
- Absolute neutrophil count (ANC) > 1.5 x 10^3/uL
- Platelet count >= 100 x 10^3/uL
- Hemoglobin >= 9 g/dL
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x ULN if participant has liver metastases, ≤5x ULN.
- Creatinine < ULN (institutional normal)
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or they are naturally postmenopausal for at least 12 consecutive months
- Females of childbearing potential must be willing to abstain from heterosexual activity or must agree to use adequate contraception (hormonal or barrier method) for the duration of study participation and for 90 days after discontinuation of study treatment
- Ability of the subject to understand and comply with study procedures for the entire length of the study
- Able to swallow ONC201
- Be willing to discontinue vitamin and mineral supplements for the duration of the study if randomized to receive the methionine restricted diet
Who cannot join
- No prior therapy with TRAIL receptor agonists
- Active infection requiring systemic therapy. Patients with a known history of human immunodeficiency virus (HIV) must have a CD4 count >= the institutional lower limit of normal within 28 days prior to registration. Patients with HIV must also be on a stable antiretroviral regimen for >= 28 days before registration
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years
- Treatment with any investigational drug agent =< 14 days prior to registration or within 5 half-lives of that investigational product, whichever is longer
- Participant who has had major surgery =< 14 days prior to registration or has not recovered from major side effects of the surgery (tumor biopsy is not considered as major surgery)
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- Known hypersensitivity to any of the excipients of ONC201
- Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
- Participants who follow a vegan or vegetarian diet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. MR diet is a methionine-free amino acid modified medical food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating participants with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine objective response rate (ORR) to ONC201 with a methionine-restricted diet in patients with metastatic triple negative breast cancer (TNBC).
SECONDARY OBJECTIVES:
- To determine progression-free survival (PFS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
II. To determine clinical benefit rate (complete or partial response plus stable disease) (CBR) at 4 months to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
III. To determine overall survival (OS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
IV. To assess metabolic indices in patients with metastatic TNBC treated with ONC201 and a methionine-restricted diet.
- To assess the expression of TRAIL receptor in circulating tumor cells (CTCs) prior, during and upon progression in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet.
EXPLORATORY OBJECTIVES:
- To determine time to development of brain metastases or worsening of brain metastases in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet.
STUDY DESIGN Patients with metastatic TNBC will be enrolled in a single-arm study evaluating ONC201 with a methionine-restricted diet.
After completion of study treatment, participants are followed up every 3 months for 2 years.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Akt/ERK Inhibitor ONC201, Methionine-Restricted Diet
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akt/ERK Inhibitor ONC201Drug
Also called ONC201, TIC10
Given PO
Methionine-Restricted DietDietary supplement
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Akt/ERK inhibitor ONC201 | Experimental | Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Akt/ERK Inhibitor ONC201 |
| Akt/ERK inhibitor ONC201, methionine-restricted diet | Experimental | Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Akt/ERK Inhibitor ONC201; Dietary Supplement: Methionine-Restricted Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) - Number of Participants Who Responded to Treatment
ORR will be estimated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, by dividing the total number of responders (complete plus partial responses plus CR or PR) or (CR or PR), respectively, by number of subjects with measurable disease and the exact 95% confidence interval will be provided.
Due to early termination with few participants, only the counts of events have been reported.
Measured: maximum follow up time was 1 year
Secondary outcomes (5)
Progression-free Survival (PFS) - Number of Participants With PFS
Will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided.
Due to early termination with few participants, only the counts of events have been reported.
Measured: maximum follow up time was 1 year
Overall Survival (OS) - Number of Participants Who Survived the Study Period
Will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided.
Due to early termination with few participants, only the counts of events have been reported.
Measured: maximum follow up time was 1 year
Clinical Benefit Rate (CBR) - Number of Participants Who Experienced Clinical Benefit
CBR will be estimated according to RECIST 1.1, by dividing the total number of responders (complete plus partial responses plus CR or PR or stable disease [SD]), by number of subjects with measurable disease and the exact 95% confidence interval will be provided.
Due to early termination with few participants, only the counts of events have been reported.
Measured: At 4 months
Duration of Response (DOR)
Will be measured using Kaplan-Meier methodology. A 95% confidence interval will be provided for the median duration of response.
Measured: Up to 2 years
Incidence of Adverse Events - Number of Participants Who Experienced Adverse Events
Incidence of adverse events as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0. Safety and tolerability will be assessed by frequency tables. Also, metabolic indices in patients with metastatic triple negative breast cancer (TNBC) treated with ONC-201 and a methionine-restricted diet will be assessed by frequency tables and descriptive statistics.
Measured: 30 days after last dose of study drug, up to 4 months on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start13 Nov 2018
- Primary completion13 Feb 2021
- Study completion13 Feb 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Kari Wisinski, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733119
- Sponsor's protocol ID
- UW17107
- Other IDs
- 2018-0252, A534260, SMPH/MEDICINE/HEM-ONC, NCI-2018-01878, Protocol Version 02/16/2021
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2018
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao M, Qin R, Huang W, Zhu HP, Peng F, Han B, Liu B. Targeting regulated cell death (RCD) with small-molecule compounds in triple-negative breast cancer: a revisited perspective from molecular mechanisms to targeted therapies. J Hematol Oncol. 2022 Apr 12;15(1):44. doi: 10.1186/s13045-022-01260-0.
PubMed 35414025
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03733119
- Acronym / sponsor ID
- UW17107
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- The V Foundation for Cancer Research
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 13 Feb 2021 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 10 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. MR diet is a methionine-free amino acid modified medical food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating participants with breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine objective response rate (ORR) to ONC201 with a methionine-restricted diet in patients with metastatic triple negative breast cancer (TNBC).
SECONDARY OBJECTIVES:
- To determine progression-free survival (PFS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
II. To determine clinical benefit rate (complete or partial response plus stable disease) (CBR) at 4 months to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
III. To determine overall survival (OS) to ONC201 with a methionine-restricted diet in patients with metastatic TNBC.
IV. To assess metabolic indices in patients with metastatic TNBC treated with ONC201 and a methionine-restricted diet.
- To assess the expression of TRAIL receptor in circulating tumor cells (CTCs) prior, during and upon progression in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet.
EXPLORATORY OBJECTIVES:
- To determine time to development of brain metastases or worsening of brain metastases in patients with metastatic TNBC treated with ONC201 with a methionine-restricted diet.
STUDY DESIGN Patients with metastatic TNBC will be enrolled in a single-arm study evaluating ONC201 with a methionine-restricted diet.
After completion of study treatment, participants are followed up every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Akt/ERK inhibitor ONC201 | Experimental | Drug: Akt/ERK Inhibitor ONC201Participants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Akt/ERK inhibitor ONC201, methionine-restricted diet | Experimental | Drug: Akt/ERK Inhibitor ONC201, Dietary Supplement: Methionine-Restricted DietParticipants receive Akt/ERK inhibitor ONC201 PO on days 3, 10, and 17. Participants also receive methionine-restricted diet PO on days 1-5, 8-12, and 15-19. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Metastatic or unresectable TNBC (estrogen receptor [ER] < 10%, progesterone receptor [PR] < 10% and HER2 negative either by immunohistochemistry [IHC] or in situ hybridization method by American Society of Clinical Oncology [ASCO]-College of American Pathologists [CAP] guidelines). For patients with a previous tumor sample with positive ER, PR and/or HER2 results, if the most recent biopsy meets study criteria, they will be eligible.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. within 28 days prior to registration
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
- Any number of prior lines of systemic therapy for metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Key exclusion criteria (10 listed)
- No prior therapy with TRAIL receptor agonists
- Active infection requiring systemic therapy. Patients with a known history of human immunodeficiency virus (HIV) must have a CD4 count >= the institutional lower limit of normal within 28 days prior to registration. Patients with HIV must also be on a stable antiretroviral regimen for >= 28 days before registration
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years
- Treatment with any investigational drug agent =< 14 days prior to registration or within 5 half-lives of that investigational product, whichever is longer
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 |
|---|---|---|
| Akt/ERK Inhibitor ONC201Also: ONC201, TIC10Given PO | Drug | Akt/ERK inhibitor ONC201, Akt/ERK inhibitor ONC201, methionine-restricted diet |
| Methionine-Restricted DietGiven PO | Dietary supplement | Akt/ERK inhibitor ONC201, methionine-restricted diet |
Primary outcome
Overall Response Rate (ORR) - Number of Participants Who Responded to Treatment
Time frame: maximum follow up time was 1 year
ORR will be estimated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, by dividing the total number of responders (complete plus partial responses plus CR or PR) or (CR or PR), respectively, by number of subjects with measurable disease and the exact 95% confidence interval will be provided. Due to early termination with few participants, only the counts of events have been reported.
5 secondary outcomes
Progression-free Survival (PFS) - Number of Participants With PFS
Time frame: maximum follow up time was 1 year
Overall Survival (OS) - Number of Participants Who Survived the Study Period
Time frame: maximum follow up time was 1 year
Clinical Benefit Rate (CBR) - Number of Participants Who Experienced Clinical Benefit
Time frame: At 4 months
Duration of Response (DOR)
Time frame: Up to 2 years
Incidence of Adverse Events - Number of Participants Who Experienced Adverse Events
Time frame: 30 days after last dose of study drug, up to 4 months on study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35414025Liao M, Qin R, Huang W, Zhu HP, Peng F, Han B, Liu B. Targeting regulated cell death (RCD) with small-molecule compounds in triple-negative breast cancer: a revisited perspective from molecular mechanisms to targeted therapies. J Hematol Oncol. 2022 Apr 12;15(1):44. doi: 10.1186/s13045-022-01260-0.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
- 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.
Kari Wisinski, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Akt/ERK Inhibitor ONC201 and Methionine-Restricted Diet in people with Triple Negative Breast Cancer, run by University of Wisconsin, Madison at 1 site 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 20 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) - Number of Participants Who Responded to Treatment (time frame: maximum follow up time was 1 year). 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 NCT03733119, 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 10 Mar 2022.