Metastatic Breast CancerPhase 1/2NCT00454532

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

A Phase 1/2 study testing BZL101 in people with Metastatic Breast Cancer, run by Bionovo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: BZL101
How many people: 27 participants
Where: No sites listed yet
Study dates: Mar 2007to Dec 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women 18 years or older
Histologically confirmed breast cancer
Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
Availability of estrogen and progesterone receptor status
At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer

Show all 9Show fewer

Life expectancy ≥ 12 weeks
Eastern Cooperative Oncology Group performance status ≤2
Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.

Who cannot join

Inability to understand/unwillingness to sign a written informed consent
Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
Currently using an investigational agent
Clinically significant gastrointestinal abnormalities
Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
Concurrent palliative radiation or anti-cancer treatment
Women who report pregnancy, are breast-feeding or have a positive pregnancy test

About this study

Official title: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.

Conditions: Metastatic Breast Cancer
Being tested: BZL101
Keywords: Breast Cancer, Bionovo, BZL101, Chinese Herbs
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BZL101Drug
Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.

What is being measured

The primary outcome is the main question the study is designed to answer.

Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Measured: Monthly
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Best Overall Tumor Response - Investigator Assessment
Measured: 2 Months
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Best Overall Tumor Response - Independent Radiology Assessment
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Dec 2009

First posted30 Mar 2007 (estimated)
Study startMar 2007
Primary completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00454532
Sponsor's protocol ID: BZL-101-002
Status last verified: Feb 2012
First submitted: 26 Mar 2007
Last updated: 16 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Perez AT, Arun B, Tripathy D, Tagliaferri MA, Shaw HS, Kimmick GG, Cohen I, Shtivelman E, Caygill KA, Grady D, Schactman M, Shapiro CL. A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients with metastatic breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):111-8. doi: 10.1007/s10549-009-0678-5.
PubMed 20054647

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.
ClinicalTrials.gov ID: NCT00454532
Acronym / sponsor ID: BZL-101-002
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer, Bionovo, BZL101, Chinese Herbs
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: BionovoIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Dec 2009 (actual)
First posted: 30 Mar 2007 (estimated)
Results: Posted 16 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Women 18 years or older
Histologically confirmed breast cancer
Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
Availability of estrogen and progesterone receptor status
At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy

Key exclusion criteria (7 listed)

Inability to understand/unwillingness to sign a written informed consent
Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
Currently using an investigational agent
Clinically significant gastrointestinal abnormalities
Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BZL101Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.	Drug	–

Primary outcome

Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Time frame: Monthly
Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Time frame: 2 Months
Best Overall Tumor Response - Investigator Assessment
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Time frame: 2 months
Best Overall Tumor Response - Independent Radiology Assessment

Results and safety

Results posted to the registry on 16 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Level 1	11	11
Level 2	6	6
Level 3	3	3
Level 4	7	7

Primary outcome: Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)

Time frame: Monthly. Number. Unit: participants

Measure	Level 1 n = 11	Level 2 n = 6	Level 4 n = 7
Elevated AST	1	0	0
Diarrhea	0	1	0
Fatigue	0	1	0
Pain-rib cage	0	0	1

Primary outcome: Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)

Time frame: 2 Months. Number. Unit: participants

Measure	Level 1 n = 11	Level 2 n = 6	Level 3 n = 3	Level 4 n = 7
Complete Response and Partial Response	0	0	0	0
Stable Disease	2	3	0	0
Progressive Disease	7	3	3	6
Unknown	2	0	0	1

Primary outcome: Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)

Time frame: 2 months. Number. Unit: participants

Measure	Level 1 n = 11	Level 2 n = 6	Level 3 n = 3	Level 4 n = 7
Complete Response and Partial Response	0	0	0	0
Stable Disease	3	2	0	1
Progressive Disease	0	3	2	3
Unknown	8	1	1	3

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Level 1	5 of 11 (45.5%)	11 of 11 (100%)	Not reported
Level 2	0 of 6 (0%)	6 of 6 (100%)	Not reported
Level 3	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Level 4	4 of 7 (57.1%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20054647Perez AT, Arun B, Tripathy D, Tagliaferri MA, Shaw HS, Kimmick GG, Cohen I, Shtivelman E, Caygill KA, Grady D, Schactman M, Shapiro CL. A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients with metastatic breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):111-8. doi: 10.1007/s10549-009-0678-5.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah Grady, M.D. principal investigator

University of California, San Francisco

Charles Shapiro, MD principal investigator

Ohio State University

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BZL101 in people with Metastatic Breast Cancer, run by Bionovo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) (time frame: Monthly). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.