NCT00983424

Brief Summary

The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

September 22, 2009

Last Update Submit

September 13, 2013

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).

    labs drawn weekly

  • To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients.

    at study completion (estimated at 2 years)

Secondary Outcomes (1)

  • To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.

    every 6-8 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

Cyclosporine A + nab-paclitaxel

Drug: CyclosporinsDrug: nab-paclitaxel

Interventions

CyclosporinsDRUG

dose escalation, administered orally twice a day

Also known as: Neoral, Gengraf
Treatment arm
nab-paclitaxelDRUG

100 mg/m2 IV days 1, 8 and 15

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male patients with adenocarcinoma of the breast with metastatic disease.
  • Patients may have evaluable or measurable disease.
  • Age \> 18 years.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Able to swallow and retain oral medication.

You may not qualify if:

  • Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
  • Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
  • Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
  • Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
  • HIV-positive patients are excluded since Cyclosporine A may result in further immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CyclosporinsCyclosporine130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • William Gradishar, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 24, 2009

Study Start

February 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 16, 2013

Record last verified: 2013-09

Locations

US(1)