Open-Label Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2022
  • participants needed
    45
  • sponsor
    Spectrum Pharmaceuticals, Inc
Updated on 21 November 2020
platelet count
cancer
cyclophosphamide
breast cancer
docetaxel
blood draw
immunostimulant
breast cancer staging
mammogram
early-stage breast cancer

Summary

The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.

Description

This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer .

Approximately 45 patients will be enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms.

Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of Cycle 1, patients will receive Docetaxel and Cyclophosphamide (TC)chemotherapy followed by administration of Eflapegrastim at 1 of 3 time schedules post-TC (30mins, 3 hours or 5 hours). During Cycles 2-4, patients will receive Eflapegrastim 24 hours after TC administration (on Day 2).

Safety evaluations will be conducted once the first 3 patients in each arm have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.

Details
Treatment cyclophosphamide, docetaxel, Eflapegrastim
Clinical Study IdentifierNCT04187898
SponsorSpectrum Pharmaceuticals, Inc
Last Modified on21 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Neutropenia or Breast Cancer?
Do you have any of these conditions: Leukopenia or Breast Cancer or breast carcinoma or cancer, breast or Neutropenia or Breast Cancer Diagnosis?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or Leukopenia or Neutropenia or Breast Cancer or breast carcinoma?
Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
Candidate to receive adjuvant or neoadjuvant TC chemotherapy
ANC 1.510^9/L
Platelet count 10010^9/L
Hemoglobin >10 g/dL
Calculated creatinine clearance > 50 mL/min
Total bilirubin 1.5 mg/dL
AST/SGOT and ALT/SGPT 2.5ULN. (upper limit of normal)
Alkaline phosphatase 2.0ULN
ECOG 2
Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation
Negative urine pregnancy test within 30 days before randomization

Exclusion Criteria

Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
Known sensitivity to E. coli derived products
Concurrent adjuvant cancer therapy other than the trial-specified therapies
Locally recurrent/metastatic breast cancer
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug
Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment
Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
Prior bone marrow or stem cell transplant
Prior radiation therapy within 30 days prior to enrollment
Major surgery within 30 days prior to enrollment
Pregnant or breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet