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HER2-negative Breast CancerPhase 1NCT04942054

A Study in Patients With Advanced Breast Cancer

A Phase 1 study testing Part 1, Part 2 and Part 3 in people with HER2-negative Breast Cancer and Advanced Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 6 sites in 2 countries.

Terminated

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

Official record
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Trial summary

A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Part 1, Part 2 and Part 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
6 sitesin 2 countries
Study dates
20 May 2022to 28 Feb 2023
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

  • All 3 parts of Study:
  • Male or females, Age 18 years or older
  • Histologically or cytologically diagnosed with ER+/HER2- adenocarcinoma of the breast cancer with an evidence of metastatic/loco-regionally recurrent disease/unresectable advanced disease not amenable to treatment with curative intent
  • Documentation of ER-positive, HER2-negative status determined based on a biopsy performed at or after diagnosis of local or metastatic recurrence, utilizing an assay consistent with local standards
  • Not more than 3 prior chemotherapeutic regimens
  • ECOG performance status 0-1.
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  • Resolution of all adverse events of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE v 5.0 Grade ≤1 (except alopecia)
  • Adequate organ and immune system function as indicated by laboratory values
  • Patients of childbearing potential must practice an acceptable method of birth control as judged by the Investigator
  • Female subjects must be non-lactating and non-breast feeding
  • Male subjects should not father a child and must practice an acceptable method of birth control measures Willing and available to participate for the entire study
  • Willing and able to comply with protocol requirements
  • For Part 1\& 2:
  • Patient must have evaluable disease (according to RECIST 1.1).
  • Documented disease progression or resistance to at least 1 prior endocrine therapy (with or without CDK 4/6 therapy).
  • For Part 3
  • Patient must have measurable lesions (according to RECIST 1.1)
  • Part 3a: HR+ve, HER2- MBC patients with ESR1 mutations, resistance to atleast one priro endocrine therapy
  • Part 3b: HR+ve HER2- MBC patients resistant to atleast one priro endocrine therapy
  • Part 3c: HR+ve HER2- MBC patients resistant to atleast one priro endocrine therapy, disease progression on Fulvestrant and CDK4/6i
  • Part 3d: Brain metastases secondary to ER+ve HER-ve Breast Cancer:
  • Measurable brain lesion (≥ 1) as per RANO-BM Criteria, Tretament naive/ Treated- Stable/ Not requiring immediate local therapy known/ Suspected leptomeningeal disease on Stable corticosteriod dose for 7 days prior screeing

Who cannot join

  • All 3 parts of Study
  • Major surgery <4 weeks of C1D1
  • Evidence of organ dysfunction or inadequate bone marrow reserve or any clinically significant finidngs
  • Patients with visceral crisis or impending visceral crisis and rapidly progressing disease
  • Serology tests +ve for HIV, HCV, HBsAg
  • Inability to swallow oral medication
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  • H/o any relevant allergy/hypersensitivity/idiosyncrasy to drugs/ chemically related to Study drug or its excipients
  • Received an IMP within 30 days/5 half life to C1D1
  • Prior treatment with other oral SERDs
  • Use of concomitant medication that might reasonably influence the results or interpretation of the study
  • Requires concurrent systemic anticancer treatment at any time during the study treatment period
  • Known or suspected history of significant drug abuse/Alcohol as judged by the Investigator
  • Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry
  • Malabsorption syndrome/IBD/other illness that would affect oral absorption of Study drug
  • Uncontrolled intercurrent illness that would limit compliance with study requirements / have impact on endpoints / safety
  • ≤6 months H/o MI/unstable angina, ongoing > G2 cardiac dysrhythmia, prolonged QTcF/ uncontrolled AF, coronary/peripheral artery bypass graft, HF of NYHA_Class II or greater and CVA (+TIA)
  • H/o Endometrial intraepithelial neoplasia, other malignancy < 5 yrs prior to enrollment
  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, or leptomeningeal disease as indicated by clinical symptoms (not applicable to Part 3d), carcinomatous meningitis, cerebral edema, and/or progressive growth or pulmonary lymphangitic metastases.
  • Current abnormal vaginal bleeding or symptomatic endometrial disorders.
  • For Part 2: Use of other ET that block the estrogen receptor: atleast 8 weeks before enrollment (28 weeks for fulvestrant) For Part 2: Liver-only metastases (are not evaluable by FES-PET/CT imaging)
  • For Part 3: Any brain lesion requiring immediate local therapy (which includes but is not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases) Requires increase in the dose of corticosteroids for control of CNS symptoms due to brain metastases Poorly controlled (> 2 per month ) generalized or complex partial seizures Who are taking concurrent enzyme-inducing antiepileptic drugs (EIAED) Who has evidence of significant (ie, symptomatic) intracranial haemorrhage Contra indications for repeated MRI assessments

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

India4 sites

  • HealthCare Global Enterprises Ltd

    Bangalore, Karnataka, 560027

  • HCG Manavata cancer Centre

    Nashik, Maharashtra, 422002

  • LMMF's Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Noble Hospital Pvt. Ltd.,

    Pune, Maharashtra, 411013

Other trials in India

United States2 sites

  • The University of Chicago

    Chicago, Illinois, 60637

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients

A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase Inhibitor/Fulvestrant/CDK4-6 inhibitors with or with out ESR1 mutation.

Read the detailed description

Part 1 \& 2: Approximately 51 subjects will be enrolled Part 3: Approximately 90 subjects will be enrolled

Being tested
Part 1, Part 2, Part 3

What participants receive

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

  • Part 1Drug

    Dose escalation cohort

  • Part 2Drug

    Pharmacodyanamic (PD) dose exploration cohorts

  • Part 3Drug

    Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort

Study groups in NCT04942054
Study groupRoleWhat they receive
SCO-120ExperimentalNot described
Receives: Drug: Part 1; Drug: Part 2; Drug: Part 3

What is being measured

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

  1. Incidence of dose limiting toxicities at each dose levels (Part 1 only)

    Measured: 28 Days/End of Cycle 1

  2. Incidence and severity of adverse events with each dose level

    The intensity of adverse events will be graded as per CTCAE, Version 5.0 and categorized as serious adverse events or non-serious adverse events.

    Measured: upto 30 days of last dose

Secondary outcomes (4)

  1. evaluation of Cmax (Part 1 and Part 2)

    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

    Measured: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)

  2. evaluation of tmax (Part 1 and Part 2)

    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

    Measured: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)

  3. evaluation of AUC (Part 1 and Part 2)

    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

    Measured: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)

  4. tumour response

    Measured: Every 8 weeks, for 'Time point Response (Partial Response[PR], Stable Disease[SD], Disease progression [DP] or Complete Response [CR]), Through study completion, an average of 1 year.

Timeline

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

  1. First posted28 Jun 2021
  2. Study start20 May 2022
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Why it stopped: The decision to close is due commercial reasons only

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
Not applicable
Intervention model
Sequential
Model description
This is a 3 X 3 Design, sequential doses of 300 mg, 600 mg, 800 mg, 1200 mg will be studied. Other dose strength will be studied based on results.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942054
Sponsor's protocol ID
SCO-120-19-22
Status last verified
May 2023
First submitted
11 Jun 2021
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
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 Part 1, Part 2 and Part 3 in people with HER2-negative Breast Cancer and Advanced Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 6 sites in 2 countries.

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 22 inclusion and 21 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India, 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 stopped early (reason given: The decision to close is due commercial reasons only). Results are not available in the source record.

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 of dose limiting toxicities at each dose levels (Part 1 only) (time frame: 28 Days/End of Cycle 1). The study lists 2 primary outcomes in all. 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 NCT04942054.

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 22 May 2023.

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