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Monoclonal Antibodies

Cirmtuzumab + Paclitaxel for Breast Cancer

Q: To what extent can Cirmtuzumab + Paclitaxel be a risk factor for health?

The safety rating of Cirmtuzumab + Paclitaxel is 1 on the scale from 1 to 3, as this phase 1 trial only has scant data concerning efficacy and security.

Q: What maladies is Cirmtuzumab + Paclitaxel typically prescribed for?

Cirmtuzumab in combination with Paclitaxel is a viable therapeutic option for those dealing neoplasm metastasis, kaposi <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a> and advance directives.

Q: Are there any previous reports of Cirmtuzumab and Paclitaxel being tested in tandem?

Currently, 833 studies are being conducted that investigate the combination of Cirmtuzumab and Paclitaxel. Of those active trials, 227 have reached Phase 3 status. Most of these study sites are located in Adelaide, South Australia; however, 45685 venues around the world are conducting research on this treatment regimen.

Q: Are there vacancies available to participants in this clinical trial?

At this time, the trial is not accepting new patients. It was initially posted on August 15th 2018 and last modified May 16th 2022. Right now there are 2287 trials enrolling people with <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, plus 833 studies recruiting for Cirmtuzumab + Paclitaxel therapy that prospective participants can consider.

Q: What is the current sample size for this research project?

This trial is no longer recruiting volunteers, as the last update was on May 16th 2022. For those who are interested in alternate studies, 2287 clinical trials for <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and 833 involving Cirmtuzumab + Paclitaxel are actively seeking participants.

University of California, San Diego, La Jolla, CA

Cirmtuzumab + PaclitaxelPhase 1Waitlist AvailableResearch Sponsored by Barbara Parker, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ER/PR negative (<10% of cells staining for ER or PR) breast cancer or have ER/PR positive (≥10% of cells staining for ER or PR) breast cancer that has exhausted standard endocrine therapy and/or in the opinion of the treating oncologist, warrants cytotoxic chemotherapy.

Measurable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI). Patients with bone only disease will be eligible if disease is considered measurable and a soft tissue component is present and can be biopsied.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up2 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will study cirmtuzumab in combination with paclitaxel to see if the combination is safe and has fewer side effects than paclitaxel alone. The study will also look at how well the combination works in treating patients with HER2 negative, metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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If you have nerve damage, it should be mild (Grade 1) or less.

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You cannot receive any other antibody therapy at the same time, except for denosumab for treating bone metastasis.

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If you have cancer that has spread to your brain, you can still participate in the study as long as the tumors in your brain are not causing any symptoms, have been treated with radiation therapy, and have been stable for at least 6 weeks without needing steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The rate of dose-limiting toxicities during the first 4 weeks of treatment

Secondary outcome measures

Best tumor response rate

Measurement of ROR1 expression levels and cancer stem cell populations

Objective tumor response rate

+2 more

Other outcome measures

Assessment of mechanism of action through pharmacokinetic studies

Correlates of PET/CT and cross-sectional imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cirmtuzumab + PaclitaxelExperimental Treatment1 Intervention

Cirmtuzumab 600 mg is administered intravenously on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. Paclitaxel 80 mg/m^2 is administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Barbara Parker, MDLead Sponsor

Oncternal Therapeutics, IncIndustry Sponsor

6 Previous Clinical Trials

319 Total Patients Enrolled

Media Library

Cirmtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02776917 — Phase 1

Breast Cancer Research Study Groups: Cirmtuzumab + Paclitaxel

Breast Cancer Clinical Trial 2023: Cirmtuzumab Highlights & Side Effects. Trial Name: NCT02776917 — Phase 1

Cirmtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02776917 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Cirmtuzumab + Paclitaxel be a risk factor for health?

"The safety rating of Cirmtuzumab + Paclitaxel is 1 on the scale from 1 to 3, as this phase 1 trial only has scant data concerning efficacy and security."

Answered by AI

What maladies is Cirmtuzumab + Paclitaxel typically prescribed for?

"Cirmtuzumab in combination with Paclitaxel is a viable therapeutic option for those dealing neoplasm metastasis, kaposi sarcoma and advance directives."

Answered by AI

Are there any previous reports of Cirmtuzumab and Paclitaxel being tested in tandem?

"Currently, 833 studies are being conducted that investigate the combination of Cirmtuzumab and Paclitaxel. Of those active trials, 227 have reached Phase 3 status. Most of these study sites are located in Adelaide, South Australia; however, 45685 venues around the world are conducting research on this treatment regimen."

Answered by AI

Are there vacancies available to participants in this clinical trial?

"At this time, the trial is not accepting new patients. It was initially posted on August 15th 2018 and last modified May 16th 2022. Right now there are 2287 trials enrolling people with breast cancer, plus 833 studies recruiting for Cirmtuzumab + Paclitaxel therapy that prospective participants can consider."

Answered by AI

What is the current sample size for this research project?

"This trial is no longer recruiting volunteers, as the last update was on May 16th 2022. For those who are interested in alternate studies, 2287 clinical trials for breast cancer and 833 involving Cirmtuzumab + Paclitaxel are actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer

Barbara Parker, MD 2018. "Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02776917.

All > Her 2 Positive Breast Cancer > Metastatic Breast Cancer