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Advanced Breast CancerPhase 1NCT05655598

TAS-116 Plus Palbociclib in Breast and Rb-null Cancer

A Phase 1 study testing Palbociclib Oral Product and TAS-116 in people with Advanced Breast Cancer and Treatment-Refractory Solid Tumors, run by Brown University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients: Patients with advanced breast cancer that has become worse after taking palbociclib alone Patients with cancers that have an abnormality in a gene called the "retinoblastoma gene". Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palbociclib Oral Product and TAS-116
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
12 Sep 2023to 5 Aug 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed solid tumors such as ER/PR(+), HER2(-) breast cancer, SCLC, soft tissue sarcoma, endometrial cancer, bladder cancer that has progressed on at least one standard therapy or for which there is no standard therapy. (Metastases or recurrences do not need to be histologically confirmed.)
  • Patients with breast cancer whose tumors progressed after prior palbociclib.
  • Patients with any treatment-refractory solid tumor that is RB-deficient (9 patient cohort expansion after phase Ib dose de-escalation phase). Examples include SCLC, soft tissue sarcoma, endometrial cancer, bladder cancer. Patients should have no available standard therapy.
  • Patients must have at least one area of measurable disease per RECIST Version 1.1 for solid tumors.
  • Recovered (< grade 1) from clinically significant effects of any prior surgery, radiotherapy or other anti-neoplastic therapy, except alopecia
  • Males or females age >18 years
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  • Life expectancy > 60 days as documented by treating investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
  • Patients must have normal organ and marrow function as defined in detail in the study protocol
  • Women must not pregnant and not nursing.
  • Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug (prior to Day 1 of treatment). Both males and females must agree to use effective birth control during the study (prior to the first dose and for 7 months after the last dose for females and 4 months after the last dose for males) if conception is possible during this interval. Female patients are considered to not be of childbearing potential if they have a history of hysterectomy or are post-menopausal defined as no menses for 12 months without an alternative medical cause
  • Post-menopausal women (surgical menopause or lack of menses >12 months) do not need to have a pregnancy test, please document status. (Female patients are considered to not be of childbearing potential if they have a history of hysterectomy or are post-menopausal defined as no menses for 12 months without an alternative medical cause.).
  • Patient must be able to swallow capsules and retain orally administered medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels.
  • Patients must be able to understand and willing to sign a written informed consent document and to comply with the protocol.
  • Women of childbearing potential enrolled in this study must agree to use adequate barrier birth control measures during the course of the study and for at least 7 months after the last dose on study.
  • Men enrolled in this study must agree to use adequate barrier birth control measures during the course of the study and for at least 4 months after the last treatment on study.
  • In addition to alopecia and stable peripheral neurotoxicity below grade 2, any clinical toxicity associated with previous treatment prior to enrollment must be restored to baseline or grade 1.

Who cannot join

  • Pregnant or breastfeeding women are excluded from this study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or TAS-116.
  • Patients receiving any medications or substances that are substrates, inducers, or inhibitors of the CYP3A enzyme.
  • Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  • Patients with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible. Medical condition exclusions
  • Patients may not be receiving any other investigational agents or anti-cancer therapies.
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  • Patients who have a history of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix. A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
  • Patients with known history of hepatitis C or chronic active hepatitis B.
  • Patients with known diagnosis of human immunodeficiency virus (HIV) infection.
  • Any significant ophthalmologic abnormality
  • Any other condition that may increase the risk of corneal epithelial damage
  • Corrected visual acuity < 0.5 (using the international visual acuity measurement standard)
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and sponsor, could affect the patient's participation in the study such as:
  • Uncontrolled diabetes mellitus.
  • Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by treatment with this study treatment.
  • Liver disease such as decompensated liver disease, chronic active hepatitis, or chronic persistent disorders.
  • Autoimmune and ischemic disorders (>=Grade 2).
  • Ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia within 6 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Significant gastrointestinal abnormalities, including active ulcerative colitis, chronic diarrhea associated with intestinal malabsorption, Crohn's disease, and/or prior surgical procedures affecting absorption or requirement for intravenous alimentation.
  • Patients with any comorbid medical disorder that, in the opinion of the Investigator or sponsor, may increase the risk of toxicity.
  • Patients who have a history of noninfectious (toxic, autoimmune) hepatitis or alcoholism.
  • Patients with a lifetime history of porphyria or psoriasis.
  • Patients with documented glucose-6-phosphate dehydrogenase deficiency.
  • Patients with a history of seizure disorder (except infant febrile seizures).
  • Patients with a lifetime history of dermatitis as an allergic/toxic reaction to any medication.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Impaired pulmonary function, history of interstitial lung disease (ILD) and/or pneumonitis.
  • Weight loss of >10% in the past month.Organ function and laboratory values exclusion
  • Patients who have impaired cardiac function or clinically significant cardiac disease
  • Chemotherapy, biologic therapy, targeted therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy
  • Prior treatment with HSP90 inhibitor.
  • Major surgery/surgical therapy for any cause within 4 weeks of screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined with Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors with Retinoblastoma Deficiency

The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients:

  • Patients with advanced breast cancer that has become worse after taking palbociclib alone
  • Patients with cancers that have an abnormality in a gene called the "retinoblastoma gene".
Being tested
Palbociclib Oral Product, TAS-116
Medical subject headings
Sarcoma, Endometrial Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib Oral ProductDrug

    125 mg/day (FDA approved dose) or the last tolerated dose before progression for 21 days of a 28-day cycle

  • TAS-116Drug

    120 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

  • TAS-116Drug

    80 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

  • TAS-116Drug

    40 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

Study groups in NCT05655598
Study groupRoleWhat they receive
Level 0 Starting Palbociclib with TAS-116ExperimentalNot described
Receives: Drug: Palbociclib Oral Product; Drug: TAS-116
Level -1 Palbociclib with TAS-116ExperimentalNot described
Receives: Drug: Palbociclib Oral Product; Drug: TAS-116
Level -2 Palbociclib with TAS-116ExperimentalNot described
Receives: Drug: Palbociclib Oral Product; Drug: TAS-116

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of TAS-116 with palbociclib.

    Dose Limiting Toxicities (DLTs) will include grade 4 neutropenia lasting longer than 7 days, neutropenic fever, grade 4 thrombocytopenia or any Grade 3 non-hematologic toxicity not controlled with medical management.

    Measured: Start of study treatment through 90 days after last treatment.

Secondary outcomes (1)

  1. Response rate

    Complete response (CR), partial response (PR), stable disease (SD) at RP2D will be estimated according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1)

    Measured: 2 months, 6 months, and 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.

  1. First posted19 Dec 2022
  2. Study start12 Sep 2023
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2024

Why it stopped: Lack of accrual

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05655598
Sponsor's protocol ID
BrUOG 387
Status last verified
Sep 2024
First submitted
9 Dec 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palbociclib Oral Product and TAS-116 in people with Advanced Breast Cancer and Treatment-Refractory Solid Tumors, run by Brown University 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 17 inclusion and 32 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 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 was withdrawn before enrolling participants, so there are no results.

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?

Safety and tolerability of TAS-116 with palbociclib. (time frame: Start of study treatment through 90 days after last treatment.). 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 NCT05655598.

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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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