Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

PHASE Ib: Maximum tolerated dose (MTD) / Recommended phase II dose (RP2D) of POL6326 (balixafortide)
MTD/RP2D, based on the incidence of Dose limiting toxicities (DLT) defined as the highest dose level explored at which up to one third of evaluable patients develop a DLT during the first treatment cycle.
12 - 24 months
PHASE 2: Progression free survival (PFS)
To assess the efficacy of POL6326 (balixafortide) in combination with either eribulin or nab-paclitaxel in terms of PFS as per RECIST v. 1.1 in patients with HER2-negative ABC.
from treatment initiation until objective tumor progression or death (at least 4.5 months)

Secondary Outcomes (23)

PHASE Ib: PFS
from treatment initiation until objective tumor progression or death (at least 4.5 months)
PHASE Ib: Overall response rate (ORR)
from baseline until end of study (will occur when all patients have discontinued treatment or 12 month after the last patient was enrolled on the study plus the safety follow up window of 28 days after last dose of study treatment in the last patient)
PHASE Ib: clinical benefit rate (CBR)
at least 6 months
PHASE IB: duration of response (DoR)
from the first occurrence of a documented objective response to disease progression or death, up to 12 months
PHASE Ib: maximum tumor shrinkage (MTS)
from baseline until end of study (will occur when all patients have discontinued treatment or 12 month after the last patient was enrolled on the study plus the safety follow up window of 28 days after last dose of study treatment in the last patient

Study Arms (4)

PHASE Ib - ARM A: POL6326 (balixafortide) + eribulin

EXPERIMENTAL

On day 1 and 8 of each 21-day cycle (+/- 1 day) fixed eribulin dose of 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate) combined with increasing doses of POL6326 (balixafortide) starting at a dose of 11 mg/Kg will be administered both intravenously. POL6326 (balixafortide) will be administered following a biphasic regimen (0,5 mg/Kg of POL6326 (balixafortide) dose during the first 30 min of treatment, the remaining dose during the following 3 h and 30 min for a total of 4h. Eribulin will be administered within 45 min after the end of the POL6326 (balixafortide) infusion over 2 to 5 min. Up to 4 additional cohorts may be introduced

Drug: POL6326Drug: Eribulin

PHASE Ib - ARM B: POL6326 (balixafortide) + nab-paclitaxel

EXPERIMENTAL

On day 1, 8 and 15 of each 28-day cycle (+/- 1 day) fixed nab-paclitaxel dose of 100 mg/m2 combined with increasing doses of POL6326 (balixafortide) starting at a dose of 5.5 mg/Kg will be administered both intravenously. POL6326 (balixafortide) will be administered following a biphasic regimen (0,5 mg/Kg of POL6326 (balixafortide) dose during the first 30 min of treatment, the remaining dose during the following 3 h and 30 min for a total of 4h. Nab-paclitaxel will be administered within 45 min after the end of the POL6326 (balixafortide) infusion over 30 min. Up to 5 additional cohorts may be introduced

Interventions

POL6326Drug

POL6326 (balixafortide): starting dose at 5.5 mg/Kg. Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A ) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).

Also known as: Balixafortide

PHASE 2 - ARM A: POL6326 (balixafortide) + eribulinPHASE 2 - ARM B: POL6326 (balixafortide) + nab-paclitaxelPHASE Ib - ARM A: POL6326 (balixafortide) + eribulinPHASE Ib - ARM B: POL6326 (balixafortide) + nab-paclitaxel

Eribulin

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female patients ≥18 years of age with histologically confirmed invasive breast cancer.
Able to understand and willing to sign an IRB/IEC approved written informed consent document.

Sponsors & Collaborators

MedSIR
Otherlead

MeSH Terms

Interventions

balixafortideeribulinTaxesAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenes

Study Officials

Javier Cortés, MD,PhD
International Breast Cancer Center (IBCC), Quiron Group, Barcelona (Spain)
PRINCIPAL INVESTIGATOR
Peter Kaufman, MD
University of Vermont Medical Center, Burlington (Vermont, USA)
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 1, 2021

Study Start

March 16, 2022

Actual (reported)

You may not qualify if:

Patients will be excluded from the study if they meet ANY of the following criteria:
Eribulin-based combination: patients have previously received eribulin.
Peripheral neuropathy \> Grade 1.
Prior radiotherapy to only site of disease.
Patients under concurrent local radiotherapy for pain control or life-threatening situations (e.g., spinal cord compression).
Known active uncontrolled or symptomatic CNS metastases as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases are eligible if they have been definitively treated (e.g., radiotherapy, stereotactic surgery), and are clinically stable at least 4 weeks after completion of radiation therapy and/or surgery. Stable is defined as absence of new neurological symptoms, absence of need for dexamethasone or anticonvulsants, and radiographic confirmation of stable disease (SD). Radiographic confirmation of SD 4 weeks after completion of radiation therapy is not required unless indicated by neurological exam.
Presence of carcinomatous meningitis or leptomeningeal disease.
Therapeutic radiation therapy within 14 days (seven days for limited-field palliative radiotherapy) prior to study enrollment, or patients who have not recovered from radiotherapy-related toxicities to grade ≤ 1.
History of allergic reactions or known hypersensitivity attributed to compounds of similar chemical or biologic composition to POL6326 (balixafortide), eribulin or nab-paclitaxel, or to recombinant proteins, or any excipient contained in the drug formulation for POL6326 (balixafortide), eribulin or nab-paclitaxel.
Breastfeeding or pregnancy as determined by a serum pregnancy test (β-HCG) at screening, prior to the administration of POL6326 (balixafortide) and/or eribulin and/or nab-paclitaxel. Since β-HCG over expression can be also elevated in some tumor types, a positive result should be confirmed with a validated alternative test (e.g., ultrasound).
Note: Postmenopausal women must have been amenorrhoeic for ≥ 12 months in order to be considered "of non-childbearing potential". This should be documented appropriately in the patient's medical history. More frequent assessments may be performed if medically indicated as determined by the study site Investigator, and these evaluations should be recorded in the CRF (Case Report Form).
Known HIV positivity on combination antiretroviral therapy.
Congenital long QT syndrome (LQTS) with corrected QT interval using the Fridericia formula (QTcF) ≥ 480 ms on baseline EKG.
Patients under treatment with drugs known to potentially prolong the QT interval, including class Ia and III anti-arrhythmic drugs will be either monitored for corrected QT (QTc) prolongation or excluded from participation in the trial, at the discretion of the treating physician.
Aany other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate patient participation in the clinical study.
+4 more criteria

Study Stopped

POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (23)

Study Arms (4)

PHASE Ib - ARM A: POL6326 (balixafortide) + eribulin

PHASE Ib - ARM B: POL6326 (balixafortide) + nab-paclitaxel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

PHASE 2 - ARM A: POL6326 (balixafortide) + eribulin

PHASE 2 - ARM B: POL6326 (balixafortide) + nab-paclitaxel

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (23)

Study Arms (4)

PHASE Ib - ARM A: POL6326 (balixafortide) + eribulin

PHASE Ib - ARM B: POL6326 (balixafortide) + nab-paclitaxel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

PHASE 2 - ARM A: POL6326 (balixafortide) + eribulin

PHASE 2 - ARM B: POL6326 (balixafortide) + nab-paclitaxel

You may not qualify if:

Source record