Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study in Patients With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04942054
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HER2-negative Breast Cancer Advanced Breast Cancer Hormone Receptor-positive Breast Cancer Drug: Part 1 Drug: Part 2 Drug: Part 3 Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SCO-120 Drug: Part 1
Dose escalation cohort

Drug: Part 2
Pharmacodyanamic (PD) dose exploration cohorts

Drug: Part 3
Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities at each dose levels (Part 1 only) [ Time Frame: 28 Days/End of Cycle 1 ]
  2. Incidence and severity of adverse events with each dose level [ Time Frame: upto 30 days of last dose ]
    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.


Secondary Outcome Measures :
  1. evaluation of Cmax (Part 1 and Part 2) [ Time Frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) ]
    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

  2. evaluation of tmax (Part 1 and Part 2) [ Time Frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) ]
    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

  3. evaluation of AUC (Part 1 and Part 2) [ Time Frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) ]
    Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations

  4. tumour response [ Time Frame: 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. ]

Other Outcome Measures:
  1. pharmacodynamic biomarker [ Time Frame: At Screening and End of Cycle 1' (Each Cycle of 28 days) ]
    Pharmacodynamic Biomarkers [Estrogen receptor (ER) expression, Ki67 down regulation from Tissue Biopsy, and Estrogen receptor occupancy with [(18)F] Fluoroestradiol Positron Emission Tomography (18F-FES PET) scan]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
    • 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
  2. 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).
  3. 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

Exclusion Criteria:

  1. 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
    • 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.
  2. 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)
  3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04942054


Contacts
Layout table for location contacts
Contact: Head, Clinical Developement 9122 66455645 clinical.trials@sparcmail.com

Locations
Layout table for location information
India
Narayana Multispeciality Hospital
Ahmedabad, Gujarat, India, 380023
Contact: Dr. Rushabh Kothari         
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, India, 560027
Contact: Dr. Satheesh CT         
Amrita Institute of Medical Sciences (AIMS)
Kochi, Kerala, India, 682041
Contact: Dr. Pavithran Kheechilat         
HCG Manavata cancer Centre
Nashik, Maharashtra, India, 422002
Contact: Dr. Aditya Adhav         
LMMF's Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India, 411004
Contact: Dr. Chetan Deshmukh         
Noble Hospital Pvt. Ltd.,
Pune, Maharashtra, India, 411013
Contact: Dr. Minish Jain         
Meenakshi Mission Hospital
Madurai, Tamil Nadu, India, 625107
Contact: Dr. Krishna Kumar Rathnam         
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT04942054    
Other Study ID Numbers: SCO-120-19-22
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases