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Metastatic Breast CancerPhase 1NCT06074757

Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study

A Phase 1 study testing Fulvestrant injection in people with Metastatic Breast Cancer, run by Kashiv BioSciences, LLC at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn the comparative pharmacokinetic parameters between the test product and the Reference listed drug in healthy female volunteers The main question[s] it aims to answer are: To assess the sequential dose exposure safety and tolerability of KSHN001034 injection in healthy female… Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Fulvestrant injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteJordan
Study dates
1 Mar 2023to 1 Oct 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 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is healthy female adult of population aged between 40 to 60 years old (inclusive) at screening.
  • The subject has a body weight not less than 50 Kg and according to the BMI range (18.5 - 30 Kg/m2)6 (inclusive) at screening.
  • The subject is fully vaccinated for COVID-19 at least two weeks ago, as checked at screening.
  • -. The subject is physically and mentally healthy as judged by means of medical and standard laboratory examinations at screening.
  • The findings of the subject are within the range of clinical acceptability in medical history, and physical examination, and laboratory results "other than RBC indices (MCH, MCV and MCHC), and hemoglobin, " within "normal ranges" for the laboratory tests performed or abnormalities considered insignificant and justified by the principal/clinical sub- investigator at screening.
  • The subject results are within normal range or ± 5% of medical lab reference range for all RBC indices (MCH, MCV and MCHC) and hemoglobin, at screening
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  • -. The subject's platelets count is within medical lab reference range at screening.
  • The subject has a normal ECG (12 leads), including normal QTc (below 440 msec), at screening
  • The subject's chest X-ray, performed within 6 months before screening (if available) or at screening, is normal or considered clinically acceptable with no evidence of ongoing or past serious infections, as per the investigator judgment at screening.
  • The subject vital signs in sitting position are within the following ranges at screening, and on admission day (before admission):
  • Blood Pressure:
  • Systolic: (90 - 140) mmHg Diastolic: (60-90) mmHg Body Temperature: (36.1 - 37.2) ºC Pulse rate: 60 to 100 beat per minute. Respiratory rate: 12-18 bpm.
  • Kidney function tests (Creatinine, Potassium and Sodium) are within the medical lab reference range and kidney function tests (Blood Urea Nitrogen, and uric acid) are considered clinically acceptable as per the investigator judgment at screening. If creatinine is below the lower normal limit while the other parameters are normal, it will be considered as clinically not significant unless otherwise judged by the investigator.
  • Liver function tests (AST, ALT, GGT, and bilirubin (total, direct, and indirect)) results are within the medical lab reference ranges and liver function tests (Alkaline phosphatase, total protein, and albumin) are considered clinically acceptable as per PI / SI judgment at screening.

Who cannot join

  • The subject has an evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements, as determined by the principal investigator/clinical Sub-investigator at screening or on admission day (before admission).
  • The subject has a known history or presence of any clinically significant abnormality / pathology / disease in any of the body systems, as checked at screening or on admission day (before admission).
  • The subject has a clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, active inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), short bowel syndrome, upper gastrointestinal surgery including gastric resection, or other conditions known to interfere with the metabolism or excretion of the drug as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission).
  • The subject has a history of allergy or major allergic reactions or known allergy/ hypersensitivity to the drug under investigation (Fulvestrant), or to any of the excipients (ethanol, benzyl alcohol, benzyl benzoate, castor oil refined), as checked at screening
  • The subject has a history of hypersensitivity to heparin as checked at screening.
  • The subject has a history of vaginal bleeding or discharge, bleeding diatheses, thrombocytopenia or taking anticoagulant treatment as checked at screening.
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  • The subject has symptoms suggestive of COVID-19 as judged by the principal investigator/clinical sub-investigator at screening or admission day (before admission).
  • The subject is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test at screening or on admission day (before admission).
  • The subject has consumed or does not agree to abstain from consuming any beverages or food containing alcohol from screening until donating the last PK sample of the study cohort, as checked at screening or on admission day (before admission).
  • The subject does not agree to abstain from consuming any beverages or food containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate, …etc) for at least 24 hours prior to each dosing and for 24 hrs after each dosing, as checked at screening or on admission day (before admission).
  • The subject has taken any prescribed drugs within four weeks preceding first study drug administration or doesn't agree on not taking them until donating last PK sample of the study cohort, as checked at screening or on admission day (before admission).

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Triumpharma Cro

    Amman, 11941

Other trials in Jordan

About this study

Official title: Open Label Sequential Dosing Single Ascending Dose of Four Cohort and Multiple Dose of One Cohort Pharmacokinetics Tolerability and Safety of Fulvestrant Injection as Test Product KSHN001034 vs Reference Product FASLODEX®

The goal of this clinical trial is to learn the comparative pharmacokinetic parameters between the test product and the Reference listed drug in healthy female volunteers

The main question[s] it aims to answer are:

  • To assess the sequential dose exposure safety and tolerability of KSHN001034 injection in healthy female subjects after single ascending doses from 25 mg to 500 mg and multiple doses of maximum tolerable dose from single ascending dose
  • To assess dose showing comparative bioavailability of KSHN001034 injection in comparison with Faslodex®.
Read the detailed description

Single ascending dose (SAD) of four cohorts (01, 02, 03, and 04) for the test product (25, 100, 250, and 500 mg, respectively).

Subjects who will participate in cohort no. 01 (N= 18 subjects) will be randomized to receive a single dose of the test product 25 mg (N= 10 subjects) or a single dose of the reference product 500 mg (N= 08 subjects). The randomization ratio will be 5:4 for T: R Study Part II: Multiple doses of three treatment arms will be administered in one cohort (N= 32, parallel design).

  • Two treatment arms of the test product: T1: the dose lower than maximum tolerated dose (MTD-1) determined in Study Part I, N=12 subjects.

T2: maximum tolerated dose determined in Study Part I, N=12 subjects.

  • One treatment arm of the reference product: R: 500 mg, N= 08 subjects The randomization ratio will be 3:3:2 for T1:T2: R]
Being tested
Fulvestrant injection
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Fulvestrant injectionDrug

    Also called faslodex

    phosphate ester of fulvestrant for test arm

Study groups in NCT06074757
Study groupRoleWhat they receive
cohort 1OtherTest (25mg) vs RLD (500mg) to assess the safety and tolerability of the test dose
Receives: Drug: Fulvestrant injection
cohort 2ExperimentalTest 100 mg
Receives: Drug: Fulvestrant injection
cohort 3ExperimentalTest 250 mg
Receives: Drug: Fulvestrant injection
cohort 4ExperimentalTest 500mg
Receives: Drug: Fulvestrant injection

What is being measured

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

  1. safety and tolerability

    To assess the dose exposure safety and tolerability of KSHN001034 injection in healthy female subjects after single ascending doses from 25 mg to 500 mg in sequential dosing and multiple doses of maximum tolerable dose from single ascending dose in parallel dosing

    Measured: 0-4 days

  2. bioavailability

    To assess dose showing comparative bioavailability of KSHN001034 injection in comparison with Faslodex®.

    Measured: 0-28 days

Secondary outcomes (1)

  1. fluctuation index and pharmacokinetics

    To assess fluctuation index of Test vs RLD in multiple doses and To assess comparative pharmacokinetics of KSHN001034 injection in comparison with Faslodex

    Measured: 0-28 days

Timeline

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

  1. First posted10 Oct 2023
  2. Study start1 Mar 2023
  3. Primary completion10 Sep 2023
  4. Study completion1 Oct 2023

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
Randomised
Intervention model
Sequential
Model description
open label, sequential dosing , single ascending dose and multiple dose pharmacokinetic , safety , tolerability study
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074757
Sponsor's protocol ID
KSHN001034
Status last verified
Oct 2023
First submitted
21 Aug 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fulvestrant injection in people with Metastatic Breast Cancer, run by Kashiv BioSciences, LLC at 1 site in Jordan.

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 14 inclusion and 11 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: finished, as of the sponsor's last update on 10 Oct 2023. 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 Jordan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: 0-4 days). 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 NCT06074757.

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 Oct 2023.

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