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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2006080 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20070344 | Other Identifier | Western Institutional Review Board | |
| 20140376 | Other Identifier | University of Miami |
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Withdrawal of Funding
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Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.
Study design A phase I/II clinical trial in patients with hormone refractory metastatic prostate cancer.
Primary objective phase I component of study:
To determine a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Primary objective phase II component of study:
To determine the therapeutic efficacy of combined therapy of azacitidine, docetaxel, and prednisone, in the treatment of hormone refractory metastatic prostate cancer. The primary measure of therapeutic efficacy is response, defined as prostate-specific antigen (PSA) response, complete response (CR), or partial response (PR).
Secondary endpoints are toxicity, duration of response, progression-free survival, and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - Aza + Doc | Experimental | Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim). |
|
| Phase 2 - Aza + Doc RPTD | Experimental | Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel) | Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. | Up to 1.5 years |
| Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone) | Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. | Up to 1.5 years |
| Number of Participants Achieving Prostate-specific Antigen (PSA) Response. | Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. | Up to 4.5 years. |
| Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy. | Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: "Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; " | Up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. |
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INCLUSION CRITERIA:
Patient who had histologically confirmed adenocarcinoma of the prostate.
Patient must have radiologically documented metastatic disease.
Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
Progressive disease may be documented by:
Non-measurable disease:
Measurable disease
Patient is 18 years or older.
Patient had a Karnofsky Performance Status (KPS) of at least 70% or Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
Life expectancy of > 6 months.
Patient with adequate organ function as defined as
Absolute Neutrophils Count greater than 1500 cells/mm3
Platelets greater than 100,000 cells/mm3
Hemoglobin greater than 8 g/dL,
Adequate liver function as documented by:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Singal, MD | University of Miami Sylvester Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25178642 | Background | Singal R, Ramachandran K, Gordian E, Quintero C, Zhao W, Reis IM. Phase I/II study of azacitidine, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy. Clin Genitourin Cancer. 2015 Feb;13(1):22-31. doi: 10.1016/j.clgc.2014.07.008. Epub 2014 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Level 1 - 75 Aza + 60 Doc | All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone. |
| FG001 | Phase 1: Level 2 - 75 Aza + 75 Doc |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Docetaxel | Drug | Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle. |
|
|
| Prednisone | Drug | Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle. |
|
| GADD45α methylation and expression analysis | Genetic | Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing. Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so. |
|
| Pegfilgrastim | Drug | Growth factor support.Granulocyte-colony stimulating factor (G-CSF) |
|
|
| Filgrastim | Drug | Growth factor support. Granulocyte-colony stimulating factor (G-CSF) |
|
|
| Up to 4.5 years. |
| Progression-Free Survival (PFS) | The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier. | Up to 4.5 years |
| Overall Survival (OS) | The time from the date of initiation of study treatment until date of death from any cause. | Up to 4.5 years. |
| Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy. | Up to 4.5 years |
All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone. |
| FG002 | Phase 1: Level 3 - 100 Aza + 75 Doc | All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone. |
| FG003 | Phase 1: Level 4 - 150 Aza + 75 Doc | All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone. |
| FG004 | Phase 2 - Aza + Doc Initial RPTD | All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD). |
| FG005 | Phase 2 - Aza + Doc Reduced RPTD | All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 | All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:
|
| BG001 | Phase 2 | All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD). |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | 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 - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel) | Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. | Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. | Posted | Number | mg/m2 | Up to 1.5 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone) | Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. | Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. | Posted | Number | mg | Up to 1.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Achieving Prostate-specific Antigen (PSA) Response. | Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. | Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy. | Posted | Number | participants | Up to 4.5 years. |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy. | Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: "Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; " | Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan. | Posted | Number | participants | Up to 4.5 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. | The 10 participants in both Phase 1 and Phase 2 who achieved PSA response. | Posted | Median | Full Range | weeks | Up to 4.5 years. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier. | Posted | Median | 95% Confidence Interval | months | Up to 4.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The time from the date of initiation of study treatment until date of death from any cause. | Posted | Median | 95% Confidence Interval | months | Up to 4.5 years. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy. | All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2. | Posted | Number | participants | Up to 4.5 years |
|
|
Not provided
All Phase 1 and Phase 2 participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Level 1 - 75 Aza + 60 Doc | 75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc) | 1 | 3 | 3 | 3 | ||
| EG001 | Level 2 - 75 Aza + 75 Doc | 75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc) | 0 | 4 | 4 | 4 | ||
| EG002 | Level 3 - 100 Aza + 75 Doc | 100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc) | 1 | 3 | 3 | 3 | ||
| EG003 | Level 4 - 150 Aza + 75 Doc | 150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc) | 4 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, normal ANC, Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limbs | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergy - Other | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac Arrhythmia - Other | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: trunk/genital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Injection Site Reaction | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculosketal - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral hemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Periodontal Disease | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal - Other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste Alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Watering Eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rakesh Singal MD | University of Miami | 305-243-9544 | rsingal@med.miami.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| C455861 | pegfilgrastim |
| D000069585 | Filgrastim |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >= 70 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Reduced RPTD Docetaxel (mg/m2) |
|
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Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim) |
| OG003 | Phase 1: Level 4 - 150 Aza + 75 Doc | Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim) |
| OG004 | Phase 2 - Aza + Doc Initial RPTD | Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim). |
| OG005 | Phase 2 - Aza + Doc Reduced RPTD | All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD). |
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| OG002 |
| Phase 1: Level 3 - 100 Aza + 75 Doc |
Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim) |
| OG003 | Phase 1: Level 4 - 150 Aza + 75 Doc | Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim) |
| OG004 | Phase 2 - Aza + Doc Initial RPTD | Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim). |
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