Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.
The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All participants enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine (Vidaza) | Drug | 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Percentage of Participants Responding to Treatment | Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria. | 6 months |
| Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria | Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized. For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ER+ Status | Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days). | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hung T Khong, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 | Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle |
| FG001 | Phase II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nab-paclitaxel (Abraxane) | Drug | 100mg/m2 weekly for 3 weeks of each 4-week cycle |
|
|
| Progression-free Survival | Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse. | 2 years |
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
| COMPLETED |
|
| NOT COMPLETED |
|
|
In the Phase I cohort, two patients stopped during Cycle I due to disease progression, and one was removed in cycle 4 due to noncompliance. In the Phase II cohort, one patient opted out after 1 cycle because of toxicity.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase II | Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 |
| BG001 | Phase I | Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I: Percentage of Participants Responding to Treatment | Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria. | 16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1. | Posted | Number | 95% Confidence Interval | percent of participants with response | 6 months |
|
|
| |||||||||||||||||||||||||
| Primary | Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria | Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized. For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. | Posted | Number | 95% Confidence Interval | percentage of participants | 1.5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With ER+ Status | Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days). | Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status. | Posted | Number | participants were ER+ | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse. | Data were not collected. | Posted | 2 years |
|
|
Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities.
Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I and II | Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 | 0 | 30 | 0 | 30 | 30 | 30 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| chills | General disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hot flashes | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Investigations | Systematic Assessment |
| ||
| Injection Site Reaction | General disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| White Blood Cell Decreased | Investigations | Systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Systematic Assessment |
| ||
| Mucositis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nail ridging | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Neutropenia | Investigations | Systematic Assessment |
| ||
| Non-Cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Rash | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| taste alteration | General disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Dyspnea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Puritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberlee Taylor | Huntsman Cancer Institute | 8012135673 | Kimberlee.Taylor@hci.utah.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|