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Breast Cancer Stage IVPhase 2NCT04123704

Sitravatinib in Metastatic Breast Cancer

A Phase 2 study testing Sitravatinib in people with Breast Cancer Stage IV and Triple Negative Breast Cancer, run by Xiang Zhang at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 100 mg daily, until their cancer worsens, or until they develop intolerable side effects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sitravatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
22 Sep 2021to 22 Jan 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women or men age 18 and older
  • Metastatic or locally advanced inoperable breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Note: Patients with bone-only disease are eligible if there is at least 1 lytic lesion that can be followed for response.
  • Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of 2010.
  • Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
  • Patient has archival tissue from metastatic or locally advanced breast cancer for the analysis of PTPN12 status
  • At least one prior line of chemotherapy with or without a PD-L1 or PD-1 antibody in the metastatic setting
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  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Normal organ and marrow function as defined below:
  • Absolute neutrophil count > 1000/mcL
  • Hemoglobin > 11 g/dL
  • Platelets > 100,000/mcL
  • Total bilirubin < 1.5 X normal institutional limits
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 X institutional ULN or ≤ 5.0 × ULN for patients with documented liver metastases.
  • Creatinine within normal institutional limits
  • Creatinine clearance ≥ 30 mL/min
  • Normal left ventricular ejection (LVEF) function defined as normal left ventricular wall motion and ejection fraction of ≥ 50%.
  • If patient has brain metastasis, documented treatment and stability for at least 30 days by scans and off steroids at the time of enrollment
  • Women of child bearing age and actively menstruating must have a negative pregnancy test prior to starting study treatment.
  • If sexually active in a way that could lead to pregnancy, participant must agree to use a highly effective method of birth control starting at the time of informed consent and continuing throughout the study and for at least 3 months after the final dose of sitravatinib.
  • Ability to understand and the willingness to give informed consent

Who cannot join

  • Uncontrolled hypertension defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100, on two or more occasions within 30 days prior to enrollment.
  • Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
  • Untreated brain metastases.
  • Women who are pregnant or nursing
  • Concurrent metastatic disease of another tumor type
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sitravatinib
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  • History of stroke, pulmonary embolus (PE), or myocardial infarction (MI)
  • Known proteinuria of ≥ 2 g urinary protein/24 h
  • HIV-positive participants
  • History of Hepatitis C or Hepatitis B infection
  • History of congestive heart failure (CHF), and/or LVEF less than 50%
  • Concurrent use of medications that prolong QTc (listed in Section 9, Table 11). These medications need to be discontinued at least 2 weeks prior to starting study treatment.
  • Concurrent medical condition that, in the sole judgment of the principal investigator, would make the patient inappropriate for trial participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer

This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 100 mg daily, until their cancer worsens, or until they develop intolerable side effects.

Being tested
Sitravatinib
Keywords
triple negative, metastatic breast cancer, sitravatinib
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • SitravatinibDrug

    Also called MGCD516

    sitravatinib capsule

Study groups in NCT04123704
Study groupRoleWhat they receive
SitravatinibExperimentalSitravatinib 100 mg daily
Receives: Drug: Sitravatinib

What is being measured

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

  1. Efficacy: Progression-Free Survival at 24 Weeks (PFS24)

    Progression-free survival 24 weeks after starting study treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, >=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.

    Measured: 24 weeks

Secondary outcomes (4)

  1. Time to Progression (TTP)

    Time to progression is defined as the duration of time from initiation of study treatment until progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, >=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.

    Measured: Up to 16 months

  2. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) to treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 16 months

  3. Clinical Benefit Rate (CBR)

    Clinical benefit rate is defined as the percentage of participants who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither >=30% decrease in sum of longest diameter of target lesions nor >=20% increase in sum of shortest diameter of target lesions.

    Measured: Up to 16 months

  4. Number of Participants With Grade 3 or Higher AEs

    Adverse events will be assessed and graded per the NCI CTCAEv5.

    Measured: Up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2019
  2. Study start22 Sep 2021
  3. Primary completion22 Jan 2023
  4. Study completion22 Jan 2023

Why it stopped: Terminated by sponsor due to lack of interest

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123704
Sponsor's protocol ID
H-43432
Status last verified
Jun 2024
First submitted
9 Oct 2019
Last updated
26 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitravatinib in people with Breast Cancer Stage IV and Triple Negative Breast Cancer, run by Xiang Zhang 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 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: stopped early, as of the sponsor's last update on 26 Aug 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 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 26 Aug 2024). 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?

Efficacy: Progression-Free Survival at 24 Weeks (PFS24) (time frame: 24 weeks). 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 NCT04123704.

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 26 Aug 2024.

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