← Back to Search

Microtubule Inhibitor

Phase I/II: Chemotherapy ABT-751 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Jeff Sosman, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date on study to date of death from any cause
Awards & highlights
No Placebo-Only Group

Summary

RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease
Secondary study objectives
Median Time to Tumor Progression
Number of Patients With Objective Response (CR & PR) by RECIST
Overall Survival
+1 more

Side effects data

From 2015 Phase 2 trial • 92 Patients • NCT00436852
39%
Leukocytes (total WBC)
39%
Neutrophils/granulocytes (ANC/AGC)
30%
" Fatigue (asthenia, lethargy, malaise)"
30%
Platelets
30%
Nausea
27%
Neuropathy: sensory
27%
Hemoglobin
25%
Pain - Extremity-limb
20%
"ALT, SGPT (serum glutamic pyruvic transaminase)"
20%
Pain - Abdomen NOS
18%
Constipation
16%
Anorexia
16%
"Hyperglycemia: Glucose, serum-high (hyperglycemia)"
16%
Pain - Head/headache
16%
"AST: AST, SGOT(serum glutamic oxaloacetic transaminase)"
14%
"Hyponatremia: Sodium, serum-low (hyponatremia)"
14%
" Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"
14%
Vomiting
14%
Insomnia
11%
Diarrhea
11%
Lymphopenia
9%
Dehydration
9%
GGT: GGT (gamma-Glutamyl transpeptidase)
9%
Weight loss
9%
"Hypokalemia: Potassium, serum-low (hypokalemia)"
9%
Pain - Joint
9%
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
9%
Cough
7%
"Hypomagnesemia: Magnesium, serum-low (hypomagnesemia)"
7%
Pain - Back
7%
Pain - Stomach
7%
Pain - Throat/pharynx/larynx
7%
Mood alteration - Anxiety
7%
Mood alteration - Depression
5%
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
5%
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
5%
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
2%
Infection (clinical or microbiological Dx) w/ Gr 3-4 neutrophils, ANC<1.0x10e9 - Paranasal
2%
Syncope (fainting)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
2%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
2%
Hemorrhage, GI - Rectum
2%
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
2%
Death not associated with CTCAE term - Death NOS
2%
Hypotension
2%
Personality/behavioral
2%
Infection with unknown ANC - Middle ear (otitis media)
2%
Pain - Bone
2%
" Bronchospasm, wheezing"
2%
Left ventricular systolic dysfunction
2%
Mood alteration - Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Disease Evaluable by I-MIBG Scintigraphy (ABT-751)
Measurable Disease by CT or MRI Scan (ABT-751)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I/II: Chemotherapy ABT-751Experimental Treatment1 Intervention
Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT-751
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
217 Previous Clinical Trials
63,529 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,183 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,907 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,933 Patients Enrolled for Prostate Cancer
Jeff Sosman, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
~1 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top