OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone
Study Details
Study Description
Brief Summary
This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to continuing abiraterone acetate and prednisone treatment in men with metastatic castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA) progression
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OUTLINE: This is a multi-center study.
This is an open-label, randomized, Phase II clinical trial designed to evaluate the anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of PSA progression but no evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases).
Patients on the control arm will be allowed to cross-over to receive OGX-427 following documented disease progression. Patients will be randomized with equal probability to one of the following arms:
EXPERIMENTAL ARM (Arm A):
OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and prednisone 10-20 mg PO daily
CONTROL ARM (Arm B):
Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone 10-20 mg PO daily
After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and exclusion criteria have been met)
Both Arms:
Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60 assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at 16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression. Patients who are withdrawn from the study for a reason other than documented disease progression or patient withdrawal of consent will be followed every 4 weeks in the Off-Treatment Follow-up Period until documented disease progression.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life Expectancy: Not Specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and hemoglobin ≥ 9 g/dL without transfusion
Hepatic:
-
Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required
-
Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN
Renal:
- Creatinine ≤ 1.3 x ULN
Cardiac:
- Known left ventricular ejection fraction (LVEF) <50% or New York Heart Association (NYHA) Functional Classification Class III or IV heart failure
Other:
-
Castrate serum testosterone level (< 50 ng/dL or < 1.7 nmol/L)
-
Potassium within normal limits
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Arm A OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone |
Drug: OGX-427
OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
Drug: Abiraterone Acetate
Standard therapy: Abiraterone Acetate 1000 mg PO daily
Drug: Prednisone
Standard therapy: Prednisone 10-20 mg PO daily
|
| Active Comparator: Control Arm: Arm B Continuation of standard therapy with abiraterone acetate and prednisone |
Drug: Abiraterone Acetate
Standard therapy: Abiraterone Acetate 1000 mg PO daily
Drug: Prednisone
Standard therapy: Prednisone 10-20 mg PO daily
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival [60 days]
To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.
Secondary Outcome Measures
- PSA Response [60 days]
Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.
Other Outcome Measures
- Objective Response [60 days]
Compare arms to determine the objective response of study patients, per RECIST 1.1
- Time to Disease Progression [60 days]
Compare arms to determine the time to disease progression of study patients
- Circulating Tumor Cell (CTC) Counts [Every 4 weeks]
Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study
- Protein Levels [Every 4 weeks]
Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study
- Phosphatase and Tensin Homolog (PTEN) Deletion Status [Every 4 weeks]
Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must meet ALL of the following criteria to be eligible for inclusion into the study.
-
Histological or cytological diagnosis of adenocarcinoma of the prostate
-
Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or bone scan
-
Currently receiving abiraterone acetate and prednisone and meeting the following criteria:
-
Any PSA decline within 12 weeks from initiation of abiraterone acetate
-
Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone (10-20 mg oral daily)
-
PSA progression, defined as an increase in PSA which is ≥25% above the nadir and an absolute value of ≥2 ng/mL, which is confirmed by a second value ≥2 weeks later.
-
No evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases or >33% increase in daily opioid use within 2 weeks prior to randomization).
-
All patients who have not had a surgical orchiectomy must continue treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a castrate level of testosterone.
-
Patient must fulfill "Prior Therapy" criteria as follows:
-
Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have passed since the last dose of chemotherapy.
-
Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is required.
-
Experimental therapy: prior non-cytotoxic experimental therapy is permitted provided a minimum of at least 14 days has passed since completing therapy. Prior treatment with enzalutamide (MDV3100) is allowed.
-
Radiation: prior external beam radiation is permitted provided a minimum of at least 14 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization
-
Must be willing to use effective contraception throughout study treatment and for 3 months after completion of study treatment if able to father a child.
-
Must be willing not to change (add or subtract) bone protecting therapy (bisphosphonates and/or denosumab) during the study unless changed for toxicity.
-
Written informed consent must be obtained prior to any protocol-specific procedures being performed.
Exclusion Criteria:
Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study:
-
Currently receiving abiraterone acetate in combination with any other anti-cancer agent (except prednisone)
-
Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain imaging for asymptomatic patients is not required.)
-
Cord compression requiring surgery or radiation therapy while on abiraterone treatment
-
Active second malignancy (including lymphoid malignancies such as chronic lymphocytic leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy or at high risk of recurrence during the study; not including adequately treated non melanomatous skin cancer or other solid tumors curatively treated with no evidence of disease in > 3 years
-
History of allergic reactions to therapeutic antisense oligonucleotides
-
Active autoimmune disease requiring treatment
-
Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment (i.e., either control or investigational arm), or prior exposure to OGX-427
-
Uncontrolled medical conditions such as myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
-
Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prostate Oncology Specialists, Inc. | Marina Del Rey | California | United States | 90292 |
| 2 | IU Health Bloomington Hospital | Bloomington | Indiana | United States | 47403 |
| 3 | IU Health Goshen Hospital | Goshen | Indiana | United States | 46527 |
| 4 | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 5 | IU Health Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46219 |
| 6 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46601 |
| 7 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 8 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 9 | University of New Mexico Cancer Center: Albuquerque | Albuquerque | New Mexico | United States | 87131 |
| 10 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 11 | Alberta Health Services: Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 12 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 13 | BC Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 14 | Cancer Care Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 15 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 16 | Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | Canada | H2L 4M1 |
Sponsors and Collaborators
- Costantine Albany
- Hoosier Cancer Research Network
- Achieve Life Sciences
Investigators
- Principal Investigator: Constantine Albany, M.D., Hoosier Cancer Research Network
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- GU12-159
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Period Title: Overall Study | ||
| STARTED | 36 | 36 |
| COMPLETED | 4 | 3 |
| NOT COMPLETED | 32 | 33 |
Baseline Characteristics
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B | Total |
|---|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Total of all reporting groups |
| Overall Participants | 36 | 36 | 72 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
71
|
72
|
72
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
36
100%
|
36
100%
|
72
100%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
2
5.6%
|
2
2.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
13.9%
|
3
8.3%
|
8
11.1%
|
| White |
30
83.3%
|
28
77.8%
|
58
80.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
2.8%
|
3
8.3%
|
4
5.6%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
14
38.9%
|
15
41.7%
|
29
40.3%
|
| United States |
22
61.1%
|
21
58.3%
|
43
59.7%
|
| ECOG Status (participants) [Number] | |||
| ECOG 0 |
16
44.4%
|
16
44.4%
|
32
44.4%
|
| ECOG 1 |
20
55.6%
|
20
55.6%
|
40
55.6%
|
| Median PSA (ug/L) [Median (Full Range) ] | |||
| Median (Full Range) [ug/L] |
34.19
|
18.17
|
23
|
Outcome Measures
| Title | Progression-Free Survival |
|---|---|
| Description | To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B. |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 36 | 36 |
| Number [participants] |
12
33.3%
|
6
16.7%
|
| Title | PSA Response |
|---|---|
| Description | Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization. |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 36 | 36 |
| PSA DECLINE >= 30% |
2
5.6%
|
2
5.6%
|
| PSA DELCINE >=50 % |
2
5.6%
|
1
2.8%
|
| ANY DECLINE |
13
36.1%
|
11
30.6%
|
| Title | Objective Response |
|---|---|
| Description | Compare arms to determine the objective response of study patients, per RECIST 1.1 |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 33 | 30 |
| Partial Response |
1
2.8%
|
0
0%
|
| Stable Disease |
6
16.7%
|
5
13.9%
|
| Progressive Disease |
26
72.2%
|
25
69.4%
|
| Title | Time to Disease Progression |
|---|---|
| Description | Compare arms to determine the time to disease progression of study patients |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 36 | 36 |
| Median (95% Confidence Interval) [months] |
1.9055
|
1.0842
|
| Title | Circulating Tumor Cell (CTC) Counts |
|---|---|
| Description | Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study |
| Time Frame | Every 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 32 | 30 |
| Best CTC Change from Baseline >=5 to <5 |
8
22.2%
|
4
11.1%
|
| Best CTC Change from Baseline <5 to <5 |
16
44.4%
|
15
41.7%
|
| Best CTC Change from Baseline >=5 to >=5 |
7
19.4%
|
10
27.8%
|
| Best CTC Change from Baseline<5 to >=5 |
1
2.8%
|
1
2.8%
|
| Title | Protein Levels |
|---|---|
| Description | Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study |
| Time Frame | Every 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for this secondary objective was not collected or analyzed |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 0 | 0 |
| Title | Phosphatase and Tensin Homolog (PTEN) Deletion Status |
|---|---|
| Description | Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes |
| Time Frame | Every 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for this objective was not collected or analyzed |
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B |
|---|---|---|
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Every four weeks, up to 48 weeks or disease progression. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover. | |||
| Arm/Group Title | Experimental: Arm A | Control Arm: Arm B | ||
| Arm/Group Description | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily | ||
All Cause Mortality |
||||
| Experimental: Arm A | Control Arm: Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/56 (14.3%) | 6/36 (16.7%) | ||
Serious Adverse Events |
||||
| Experimental: Arm A | Control Arm: Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/56 (21.4%) | 6/36 (16.7%) | ||
| Blood and lymphatic system disorders | ||||
| ANEMIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 2 |
| Cardiac disorders | ||||
| ATRIAL FIBRILLATION | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||||
| CONSTIPATION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| NAUSEA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| GASTROINTESTINAL DISORDERS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| General disorders | ||||
| EDEMA LIMBS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PAIN | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Infections and infestations | ||||
| INFECTIONS AND INFESTATIONS | 3/56 (5.4%) | 3 | 1/36 (2.8%) | 1 |
| URINARY TRACT INFECTION | 1/56 (1.8%) | 3 | 0/36 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| FRACTURE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| GENERALIZED MUSCLE WEAKNESS | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Nervous system disorders | ||||
| NERVOUS SYSTEM DISORDERS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Psychiatric disorders | ||||
| CONFUSION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Renal and urinary disorders | ||||
| ACUTE KIDNEY INJURY | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| CYSTITIS NONINFECTIVE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| HEMATURIA | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| RENAL AND URINARY DISORDERS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| URINARY RETENTION | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| URINARY TRACT OBSTRUCTION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| DYSPNEA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PNEUMONITIS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Experimental: Arm A | Control Arm: Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/56 (91.1%) | 32/36 (88.9%) | ||
| Blood and lymphatic system disorders | ||||
| ANEMIA | 13/56 (23.2%) | 25 | 10/36 (27.8%) | 12 |
| LEUKOCYTOSIS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| FEBRILE NEUTROPENIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Cardiac disorders | ||||
| ATRIAL FIBRILLATION | 2/56 (3.6%) | 2 | 1/36 (2.8%) | 1 |
| ATRIAL FLUTTER | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| CARDIAC DISORDERS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Ear and labyrinth disorders | ||||
| EXTERNAL EAR PAIN | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| VERTIGO | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| HEARING IMPAIRED | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Endocrine disorders | ||||
| CUSHINGOID | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| HYPOTHYROIDISM | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 2 |
| ENDOCRINE DISORDERS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| HYPERPARATHYROIDISM | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Eye disorders | ||||
| EYE DISORDERS | 2/56 (3.6%) | 2 | 2/36 (5.6%) | 2 |
| GLAUCOMA | 2/56 (3.6%) | 2 | 1/36 (2.8%) | 1 |
| VITREOUS HEMORRHAGE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| NIGHT BLINDNESS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| RETINAL VASCULAR DISORDER | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 2/56 (3.6%) | 2 | 2/36 (5.6%) | 2 |
| CONSTIPATION | 6/56 (10.7%) | 6 | 10/36 (27.8%) | 12 |
| DIARRHEA | 11/56 (19.6%) | 14 | 8/36 (22.2%) | 14 |
| DYSPEPSIA | 2/56 (3.6%) | 2 | 2/36 (5.6%) | 2 |
| GASTRITIS | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| GASTROESOPHAGEAL REFLUX DISEASE | 2/56 (3.6%) | 2 | 2/36 (5.6%) | 2 |
| GASTROINTESTINAL DISORDERS | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 4 |
| HEMORRHOIDS | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 2 |
| MUCOSITIS ORAL | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| NAUSEA | 25/56 (44.6%) | 28 | 9/36 (25%) | 11 |
| TOOTHACHE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| VOMITING | 15/56 (26.8%) | 18 | 7/36 (19.4%) | 8 |
| DRY MOUTH | 0/56 (0%) | 0 | 2/36 (5.6%) | 2 |
| DYSPHAGIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| GASTRIC ULCER | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| ILEAL ULCER | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| PROCTITIS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| STOMACH PAIN | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| General disorders | ||||
| CHILLS | 16/56 (28.6%) | 23 | 3/36 (8.3%) | 4 |
| EDEMA LIMBS | 8/56 (14.3%) | 9 | 7/36 (19.4%) | 8 |
| EDEMA TRUNK | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 3 |
| FACIAL PAIN | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| FATIGUE | 26/56 (46.4%) | 40 | 22/36 (61.1%) | 32 |
| FEVER | 11/56 (19.6%) | 12 | 2/36 (5.6%) | 2 |
| FLU LIKE SYMPTOMS | 4/56 (7.1%) | 4 | 1/36 (2.8%) | 1 |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 8/56 (14.3%) | 10 | 3/36 (8.3%) | 4 |
| LOCALIZED EDEMA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| MALAISE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| NON-CARDIAC CHEST PAIN | 2/56 (3.6%) | 3 | 1/36 (2.8%) | 1 |
| PAIN | 7/56 (12.5%) | 8 | 10/36 (27.8%) | 12 |
| Hepatobiliary disorders | ||||
| HEPATOBILIARY DISORDERS | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| Infections and infestations | ||||
| BLADDER INFECTION | 2/56 (3.6%) | 3 | 0/36 (0%) | 0 |
| BRONCHIAL INFECTION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| HEPATITIS VIRAL | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| INFECTIONS AND INFESTATIONS | 2/56 (3.6%) | 2 | 2/36 (5.6%) | 2 |
| PAPULOPUSTULAR RASH | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| SINUSITIS | 2/56 (3.6%) | 3 | 0/36 (0%) | 0 |
| UPPER RESPIRATORY INFECTION | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| URINARY TRACT INFECTION | 3/56 (5.4%) | 3 | 2/36 (5.6%) | 2 |
| RHINITIS INFECTIVE | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| SKIN INFECTION | 0/56 (0%) | 0 | 1/36 (2.8%) | 2 |
| TOOTH INFECTION | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| ANKLE FRACTURE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| BRUISING | 1/56 (1.8%) | 1 | 6/36 (16.7%) | 6 |
| FALL | 6/56 (10.7%) | 6 | 1/36 (2.8%) | 1 |
| FRACTURE | 2/56 (3.6%) | 2 | 1/36 (2.8%) | 1 |
| INFUSION RELATED REACTION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| VASCULAR ACCESS COMPLICATION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| Investigations | ||||
| ALANINE AMINOTRANSFERASE INCREASED | 9/56 (16.1%) | 17 | 0/36 (0%) | 0 |
| ALKALINE PHOSPHATASE INCREASED | 3/56 (5.4%) | 7 | 1/36 (2.8%) | 1 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 8/56 (14.3%) | 18 | 1/36 (2.8%) | 1 |
| CHOLESTEROL HIGH | 4/56 (7.1%) | 4 | 7/36 (19.4%) | 7 |
| CREATININE INCREASED | 3/56 (5.4%) | 5 | 1/36 (2.8%) | 1 |
| INVESTIGATIONS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| NEUTROPHIL COUNT DECREASED | 3/56 (5.4%) | 8 | 1/36 (2.8%) | 2 |
| PLATELET COUNT DECREASED | 5/56 (8.9%) | 11 | 3/36 (8.3%) | 6 |
| URINE OUTPUT DECREASED | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| WEIGHT LOSS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| WHITE BLOOD CELL DECREASED | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| BLOOD BILIRUBIN INCREASED | 0/56 (0%) | 0 | 2/36 (5.6%) | 6 |
| CARDIAC TROPONIN I INCREASED | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| LYMPHOCYTE COUNT INCREASED | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| WEIGHT GAIN | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Metabolism and nutrition disorders | ||||
| ACIDOSIS | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| ANOREXIA | 5/56 (8.9%) | 6 | 9/36 (25%) | 15 |
| DEHYDRATION | 4/56 (7.1%) | 5 | 2/36 (5.6%) | 2 |
| HYPERGLYCEMIA | 4/56 (7.1%) | 6 | 5/36 (13.9%) | 8 |
| HYPOCALCEMIA | 1/56 (1.8%) | 2 | 2/36 (5.6%) | 2 |
| HYPOKALEMIA | 11/56 (19.6%) | 16 | 5/36 (13.9%) | 13 |
| HYPONATREMIA | 3/56 (5.4%) | 4 | 2/36 (5.6%) | 4 |
| HYPOPHOSPHATEMIA | 2/56 (3.6%) | 3 | 1/36 (2.8%) | 2 |
| HYPOALBUMINEMIA | 0/56 (0%) | 0 | 2/36 (5.6%) | 4 |
| METABOLISM AND NUTRITION DISORDERS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| ARTHRITIS | 3/56 (5.4%) | 3 | 5/36 (13.9%) | 5 |
| BACK PAIN | 15/56 (26.8%) | 21 | 12/36 (33.3%) | 15 |
| BONE PAIN | 6/56 (10.7%) | 11 | 6/36 (16.7%) | 7 |
| BUTTOCK PAIN | 1/56 (1.8%) | 2 | 0/36 (0%) | 0 |
| FLANK PAIN | 2/56 (3.6%) | 2 | 1/36 (2.8%) | 1 |
| GENERALIZED MUSCLE WEAKNESS | 3/56 (5.4%) | 6 | 6/36 (16.7%) | 7 |
| MUSCLE WEAKNESS LOWER LIMB | 3/56 (5.4%) | 3 | 2/36 (5.6%) | 3 |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER | 4/56 (7.1%) | 4 | 3/36 (8.3%) | 4 |
| MYALGIA | 3/56 (5.4%) | 3 | 1/36 (2.8%) | 1 |
| NECK PAIN | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PAIN IN EXTREMITY | 8/56 (14.3%) | 9 | 14/36 (38.9%) | 21 |
| OSTEONECROSIS OF JAW | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| OSTEOPOROSIS | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 1/56 (1.8%) | 1 | 3/36 (8.3%) | 3 |
| Nervous system disorders | ||||
| DIZZINESS | 7/56 (12.5%) | 7 | 1/36 (2.8%) | 2 |
| DYSARTHRIA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| DYSGEUSIA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| DYSPHASIA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| HEADACHE | 8/56 (14.3%) | 9 | 5/36 (13.9%) | 5 |
| NERVOUS SYSTEM DISORDERS | 3/56 (5.4%) | 4 | 2/36 (5.6%) | 3 |
| PARESTHESIA | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| PERIPHERAL MOTOR NEUROPATHY | 2/56 (3.6%) | 3 | 1/36 (2.8%) | 1 |
| PERIPHERAL SENSORY NEUROPATHY | 6/56 (10.7%) | 6 | 7/36 (19.4%) | 9 |
| PRESYNCOPE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| SPASTICITY | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| SYNCOPE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| TREMOR | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| VASOVAGAL REACTION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| SEIZURE | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Psychiatric disorders | ||||
| AGITATION | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| ANXIETY | 4/56 (7.1%) | 4 | 4/36 (11.1%) | 4 |
| CONFUSION | 1/56 (1.8%) | 2 | 2/36 (5.6%) | 3 |
| DEPRESSION | 3/56 (5.4%) | 3 | 1/36 (2.8%) | 1 |
| INSOMNIA | 1/56 (1.8%) | 1 | 6/36 (16.7%) | 7 |
| RESTLESSNESS | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| LIBIDO DECREASED | 0/56 (0%) | 0 | 3/36 (8.3%) | 3 |
| Renal and urinary disorders | ||||
| ACUTE KIDNEY INJURY | 1/56 (1.8%) | 1 | 1/36 (2.8%) | 1 |
| BLADDER SPASM | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| CHRONIC KIDNEY DISEASE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| HEMATURIA | 1/56 (1.8%) | 1 | 3/36 (8.3%) | 3 |
| RENAL AND URINARY DISORDERS | 5/56 (8.9%) | 5 | 2/36 (5.6%) | 2 |
| URINARY FREQUENCY | 2/56 (3.6%) | 2 | 8/36 (22.2%) | 9 |
| URINARY INCONTINENCE | 2/56 (3.6%) | 3 | 1/36 (2.8%) | 1 |
| URINARY RETENTION | 1/56 (1.8%) | 1 | 6/36 (16.7%) | 6 |
| URINARY TRACT PAIN | 2/56 (3.6%) | 2 | 1/36 (2.8%) | 1 |
| URINARY URGENCY | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| CYSTITIS NONINFECTIVE | 0/56 (0%) | 0 | 2/36 (5.6%) | 2 |
| RENAL CALCULI | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Reproductive system and breast disorders | ||||
| ERECTILE DYSFUNCTION | 0/56 (0%) | 0 | 2/36 (5.6%) | 2 |
| GYNECOMASTIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| PELVIC PAIN | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| PROSTATIC OBSTRUCTION | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| SCROTAL PAIN | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| ALLERGIC RHINITIS | 2/56 (3.6%) | 2 | 4/36 (11.1%) | 4 |
| COUGH | 7/56 (12.5%) | 9 | 10/36 (27.8%) | 12 |
| DYSPNEA | 8/56 (14.3%) | 20 | 6/36 (16.7%) | 9 |
| EPISTAXIS | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 2 |
| LARYNGEAL HEMORRHAGE | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PRODUCTIVE COUGH | 3/56 (5.4%) | 4 | 1/36 (2.8%) | 1 |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 4/56 (7.1%) | 4 | 0/36 (0%) | 0 |
| SLEEP APNEA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| WHEEZING | 2/56 (3.6%) | 2 | 0/36 (0%) | 0 |
| HYPOXIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| NASAL CONGESTION | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| SORE THROAT | 0/56 (0%) | 0 | 2/36 (5.6%) | 2 |
| VOICE ALTERATION | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| ALOPECIA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| ERYTHEMA MULTIFORME | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PAIN OF SKIN | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PRURITUS | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| PURPURA | 1/56 (1.8%) | 1 | 0/36 (0%) | 0 |
| RASH MACULO-PAPULAR | 3/56 (5.4%) | 3 | 1/36 (2.8%) | 1 |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 4/56 (7.1%) | 4 | 2/36 (5.6%) | 2 |
| URTICARIA | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 3 |
| DRY SKIN | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| TELANGIECTASIA | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Surgical and medical procedures | ||||
| SURGICAL AND MEDICAL PROCEDURES | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vascular disorders | ||||
| FLUSHING | 3/56 (5.4%) | 3 | 1/36 (2.8%) | 1 |
| HOT FLASHES | 3/56 (5.4%) | 3 | 4/36 (11.1%) | 5 |
| HYPERTENSION | 12/56 (21.4%) | 17 | 18/36 (50%) | 19 |
| HYPOTENSION | 4/56 (7.1%) | 5 | 2/36 (5.6%) | 2 |
| VASCULAR DISORDERS | 1/56 (1.8%) | 1 | 2/36 (5.6%) | 2 |
| THROMBOEMBOLIC EVENT | 0/56 (0%) | 0 | 1/36 (2.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Data Coordinator |
|---|---|
| Organization | Hoosier Cancer Research Network |
| Phone | 317-921-2050 |
| jsmith@hoosiercancer.org |
- GU12-159