Metastatic Breast Cancer
Conditions
Keywords
Breast Cancer, Bionovo, BZL101, Chinese Herbs
Brief summary
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.
Interventions
DRUGBZL101
Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.
Sponsors
Bionovo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 * 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. Key
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | 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) | 2 Months | Best Overall Tumor Response - Investigator Assessment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Level 1 10g/day | 11 |
| Level 2 20g/day | 6 |
| Level 3 30g/day | 3 |
| Level 4 40g/day | 7 |
| Total | 27 |
Baseline characteristics
| Characteristic | Level 1 | Total | Level 4 | Level 3 | Level 2 |
|---|---|---|---|---|---|
| Age Continuous | 57 years | 59 years | 61 years | 55 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 22 Participants | 6 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 6 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 11 participants | 27 participants | 7 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 11 Participants | 27 Participants | 7 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 6 / 6 | 3 / 3 | 7 / 7 |
| serious Total, serious adverse events | 5 / 11 | 0 / 6 | 1 / 3 | 4 / 7 |
Outcome results
Primary
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Best Overall Tumor Response - Investigator Assessment
Time frame: 2 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 2 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 2 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 7 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 3 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 3 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 0 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 3 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 0 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 0 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 0 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 6 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 1 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
Primary
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Best Overall Tumor Response - Independent Radiology Assessment
Time frame: 2 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 0 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 8 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 3 participants |
| Level 1 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 2 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 1 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 2 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 3 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 0 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 1 participants |
| Level 3 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 2 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Progressive Disease | 3 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Complete Response and Partial Response | 0 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Stable Disease | 1 participants |
| Level 4 | Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2) | Unknown | 3 participants |
Primary
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
Time frame: Monthly
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Level 1 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Elevated AST | 1 participants |
| Level 1 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Diarrhea | 0 participants |
| Level 1 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Fatigue | 0 participants |
| Level 1 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Pain-rib cage | 0 participants |
| Level 2 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Diarrhea | 1 participants |
| Level 2 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Fatigue | 1 participants |
| Level 2 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Pain-rib cage | 0 participants |
| Level 2 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Elevated AST | 0 participants |
| Level 3 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Fatigue | 0 participants |
| Level 3 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Diarrhea | 0 participants |
| Level 3 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Pain-rib cage | 0 participants |
| Level 3 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Elevated AST | 0 participants |
| Level 4 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Pain-rib cage | 1 participants |
| Level 4 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Diarrhea | 0 participants |
| Level 4 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Elevated AST | 0 participants |
| Level 4 | Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1) | Fatigue | 0 participants |