Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02776917|
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Cirmtuzumab + Paclitaxel||Phase 1|
- This is a phase 1b, open-label, non-randomized, fixed dose study in patients with HER2 negative metastatic, or locally advanced, unresectable breast cancer.
- Cirmtuzumab and paclitaxel will be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity, as long as the subject is tolerating the drug and does not exhibit disease progression.
- Blood and tissue samples will be collected at pre-specified times to enable pharmacokinetic and correlative studies.
- Adverse events (AE) will be monitored throughout the trial. Reporting of AEs will be in accordance with CTCAE version 4.03.
- Assessment of tumor response will be performed by physical examination and/or by radiographic imaging and according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
- Patients will be assessed at 28 days following the last dose of cirmtuzumab to assess tumor response and at 56 days following the last dose of cirmtuzumab to assess any adverse events and to document any concomitant cancer therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer|
|Actual Study Start Date :||August 15, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Cirmtuzumab + Paclitaxel
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.
Drug: Cirmtuzumab + Paclitaxel
Cirmtuzumab and paclitaxel may be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity.
Other Name: UC-961, Taxol
- The rate of dose-limiting toxicities during the first 4 weeks of treatment [ Time Frame: Within 4 weeks of starting study treatment ]The proportion of clinically significant adverse events per CTCAE Version 4.03 at least possibly related to cirmtuzumab or the combination of cirmtuzumab and paclitaxel during the first four weeks of investigational treatment.
- Safety and tolerability of the combination therapy since the start of any study treatment. [ Time Frame: 12 months ]Treatment-emergent adverse events beginning from the start of study treatment to six months after study treatment completion.
- Objective tumor response rate [ Time Frame: 9 months ]The proportion of patients with complete and partial tumor responses as assessed by RECIST v1.1
- Best tumor response rate [ Time Frame: 9 months ]The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1
- Time to progression [ Time Frame: 2 years ]The duration of response measured from the time of initial response until documented tumor progression.
- Measurement of ROR1 expression levels and cancer stem cell populations [ Time Frame: 12 months ]Immunohistochemistry measurement of ROR1 expression levels and other cancer stem cell markers (ALDH, CD133) from primary pre-treatment and post-treatment tumor specimens.
- Correlates of PET/CT and cross-sectional imaging [ Time Frame: 9 months ]Comparison of PET/CT results with standard cross-sectional imaging
- Assessment of mechanism of action through pharmacokinetic studies [ Time Frame: 9 months ]Measurement of plasma pharmacokinetics of cirmtuzumab and level of circulating antibody formation against cirmtuzumab; gene expression and functional studies of stem-like cells in tumor tissue as available
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): NCT02776917
|Contact: Barbara Parker, MDemail@example.com|
|Contact: Rebecca Shatsky, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Sauntee Braddock 858-534-8248 email@example.com|
|Principal Investigator:||Barbara Parker, MD||University of California, San Diego|