Trial Outcomes & Findings for A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients (NCT NCT00503984)
NCT ID: NCT00503984
Last Updated: 2016-06-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 1.5 years
Results posted on
2016-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
Phase 1: Level 2 - 75 Aza + 75 Doc
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.
|
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.
|
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.
|
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).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
6
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
6
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Phase 1: Level 2 - 75 Aza + 75 Doc
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.
|
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.
|
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.
|
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).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Phase 1
n=15 Participants
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:
* Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc
* Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc
* Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc
* Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc
|
Phase 2
n=7 Participants
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).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 60 years
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
>= 70 years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1.5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=15 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
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)
|
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Initial RPTD Azacitidine (mg/m2)
|
150 mg/m2
|
—
|
—
|
—
|
—
|
—
|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Initial RPTD Docetaxel (mg/m2)
|
75 mg/m2
|
—
|
—
|
—
|
—
|
—
|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Reduced RPTD Azacitidine (mg/m2)
|
75 mg/m2
|
—
|
—
|
—
|
—
|
—
|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
Reduced RPTD Docetaxel (mg/m2)
|
75 mg/m2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1.5 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=15 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
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)
|
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
Initial RPTD Prednisone (mg)
|
5 mg
|
—
|
—
|
—
|
—
|
—
|
|
Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
Reduced RPTD Prednisone (mg)
|
5 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 4.5 years.Population: Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.
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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=3 Participants
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 1: Level 2 - 75 Aza + 75 Doc
n=1 Participants
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
n=3 Participants
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)
|
Phase 1: Level 4 - 150 Aza + 75 Doc
n=6 Participants
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)
|
Phase 2 - Aza + Doc Initial RPTD
n=5 Participants
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
Phase 2 - Aza + Doc Reduced RPTD
n=1 Participants
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving Prostate-specific Antigen (PSA) Response.
|
0 participants
|
1 participants
|
2 participants
|
4 participants
|
3 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 4.5 yearsPopulation: Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.
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; "
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=2 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
n=2 Participants
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)
|
Phase 1: Level 4 - 150 Aza + 75 Doc
n=3 Participants
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)
|
Phase 2 - Aza + Doc Initial RPTD
n=3 Participants
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
Complete Response (CR)
|
0 participants
|
—
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
Partial Response (PR)
|
0 participants
|
—
|
0 participants
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4.5 years.Population: The 10 participants in both Phase 1 and Phase 2 who achieved PSA 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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=10 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
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)
|
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Duration of Response
|
20.5 weeks
Interval 3.0 to 63.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsThe 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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=22 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
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)
|
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
4.9 months
Interval 1.4 to 9.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4.5 years.The time from the date of initiation of study treatment until date of death from any cause.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=22 Participants
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 1: Level 2 - 75 Aza + 75 Doc
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
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)
|
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
19.5 months
Interval 13.6 to 26.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsPopulation: 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.
Outcome measures
| Measure |
Phase 1 - Aza + Doc
n=3 Participants
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 1: Level 2 - 75 Aza + 75 Doc
n=4 Participants
Phase 1, Starting Dose Level 2: 75 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)
|
Phase 1: Level 3 - 100 Aza + 75 Doc
n=3 Participants
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)
|
Phase 1: Level 4 - 150 Aza + 75 Doc
n=12 Participants
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)
|
Phase 2 - Aza + Doc Initial RPTD
Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
|
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.
|
3 participants
|
4 participants
|
3 participants
|
12 participants
|
—
|
—
|
Adverse Events
Level 1 - 75 Aza + 60 Doc
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 2 - 75 Aza + 75 Doc
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Level 3 - 100 Aza + 75 Doc
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 4 - 150 Aza + 75 Doc
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Level 1 - 75 Aza + 60 Doc
n=3 participants at risk
75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
|
Level 2 - 75 Aza + 75 Doc
n=4 participants at risk
75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
Level 3 - 100 Aza + 75 Doc
n=3 participants at risk
100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
Level 4 - 150 Aza + 75 Doc
n=12 participants at risk
150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Chest Pain
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Fatigue
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Infections and infestations
Febrile Neutropenia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
3/12 • Number of events 3
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 3
All Phase 1 and Phase 2 participants
|
|
Infections and infestations
Infection, normal ANC, Catheter-related
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Renal and urinary disorders
Renal
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
Other adverse events
| Measure |
Level 1 - 75 Aza + 60 Doc
n=3 participants at risk
75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
|
Level 2 - 75 Aza + 75 Doc
n=4 participants at risk
75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
Level 3 - 100 Aza + 75 Doc
n=3 participants at risk
100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
Level 4 - 150 Aza + 75 Doc
n=12 participants at risk
150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
41.7%
5/12 • Number of events 62
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
75.0%
3/4 • Number of events 10
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 9
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 51
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Leukocytes
|
33.3%
1/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 19
All Phase 1 and Phase 2 participants
|
100.0%
3/3 • Number of events 12
All Phase 1 and Phase 2 participants
|
66.7%
8/12 • Number of events 72
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Neutrophils
|
100.0%
3/3 • Number of events 5
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 10
All Phase 1 and Phase 2 participants
|
100.0%
3/3 • Number of events 7
All Phase 1 and Phase 2 participants
|
50.0%
6/12 • Number of events 31
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Platelets
|
33.3%
1/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 13
All Phase 1 and Phase 2 participants
|
|
General disorders
Pain
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 2
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 9
All Phase 1 and Phase 2 participants
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 3
All Phase 1 and Phase 2 participants
|
100.0%
3/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
66.7%
8/12 • Number of events 9
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 4
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 4
All Phase 1 and Phase 2 participants
|
25.0%
3/12 • Number of events 18
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 2
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
25.0%
3/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
General disorders
Back Pain
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 7
All Phase 1 and Phase 2 participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 6
All Phase 1 and Phase 2 participants
|
|
Injury, poisoning and procedural complications
Allergic reaction
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
50.0%
2/4 • Number of events 3
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
3/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
3/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
33.3%
4/12 • Number of events 10
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 3
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Edema limbs
|
33.3%
1/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Weight loss
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Fever
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 11
All Phase 1 and Phase 2 participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 2
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 4
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Creatinine increased
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 3
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Immune system disorders
Allergy - Other
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Nervous system disorders
Anxiety
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 2
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Eye disorders
Blurred vision
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Chest Pain
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 3
All Phase 1 and Phase 2 participants
|
75.0%
3/4 • Number of events 5
All Phase 1 and Phase 2 participants
|
66.7%
2/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
58.3%
7/12 • Number of events 9
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Number of events 2
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 2
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
16.7%
2/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Injury, poisoning and procedural complications
Injection Site Reaction
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
General disorders
Insomnia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
General disorders
Joint Pain
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Musculoskeletal and connective tissue disorders
Musculosketal - Other
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
General disorders
Oral hemorrhage
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
33.3%
1/3 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
General disorders
Oral pain
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Pain in extremity
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 2
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Renal and urinary disorders
Renal - Other
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Rigors/Chills
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
General disorders
Sweating
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
25.0%
1/4 • Number of events 1
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/12
All Phase 1 and Phase 2 participants
|
|
Gastrointestinal disorders
Taste Alteration
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
|
Eye disorders
Watering Eyes
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
0.00%
0/4
All Phase 1 and Phase 2 participants
|
0.00%
0/3
All Phase 1 and Phase 2 participants
|
8.3%
1/12 • Number of events 1
All Phase 1 and Phase 2 participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place