Trial Outcomes & Findings for Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT01468532)
NCT ID: NCT01468532
Last Updated: 2021-03-25
Results Overview
To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to day 57
Results posted on
2021-03-25
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
|
Age, Continuous
|
65 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to day 57To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method.
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
60 mg
|
SECONDARY outcome
Timeframe: On days 1, 8, 15, 22, 29, 36 43, 50 and 57The count of patients who experience a given type and grade of toxicity as assessed via NCI CTCAE version 4.0
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypophosphatemia grade 3
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypotension grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypothyroidism grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Infusion related reaction grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Infusion site extravasation grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Injection site reaction grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Insomnia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Localized edema grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Lymphedema grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Lymphocyte count decreased grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Lymphocyte count decreased grade 3
|
7 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Lymphocyte count decreased grade 4
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Mucositis oral grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Muscle weakness lower limb grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Musculoskeletal and connective tissue dis. grade 1
|
5 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Myalgia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nail discoloration grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nail discoloration grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nail loss grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nail ridging grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nasal congestion grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nausea grade 1
|
10 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nausea grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Nervous system disorders - Other grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Neutrophil count decreased grade 3
|
10 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Neutrophil count decreased grade 4
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Otitis externa grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Pain grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Pain in extremity grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Pelvic pain grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Penile infection grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Penile pain grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Peripheral sensory neuropathy grade 1
|
7 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Peripheral sensory neuropathy grade 2
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Platelet count decreased grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Rash acneiform grade 1
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Rash acneiform grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Rectal pain grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Renal and urinary disorders - Other grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Renal and urinary disorders - Other grade 2
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Respiratory, thoracic and mediastinal dis. grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Serum amylase increased grade 4
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Sinus disorder grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Sinusitis grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Skin and subcutaneous tissue disorders grade 1
|
9 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Skin and subcutaneous tissue disorders grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Skin infection grade 4
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Sore throat grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Thromboembolic event grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Toothache grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Tremor grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Upper respiratory infection grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Upper respiratory infection grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Upper respiratory infection grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Urinary frequency grade 1
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Urinary tract infection grade 2
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Urinary tract infection grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Urinary tract obstruction grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Vomiting grade 1
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Watering eyes grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Weight loss grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Weight loss grade 2
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Weight loss grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Wheezing grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
White blood cell decreased grade 3
|
11 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
White blood cell decreased grade 4
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Abdominal pain grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Agitation grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Alkaline phosphatase increased grade 3
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Allergic reaction grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Alopecia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Alopecia grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Anemia grade 1
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Anemia grade 3
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Anorexia grade 1
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Anorexia grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Arthritis grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Aspartate aminotransferase increased grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Aspartate aminotransferase increased grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Back pain grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Back pain grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Bladder infection grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Blood and lymphatic system disorders-Other grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Bruising grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Cardiac disorders - Other, specify grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Cataract grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Chills grade 1
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Cholesterol high grade 1
|
5 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Conjunctivitis grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Constipation grade 1
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Cough grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Cough grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Creatinine increased grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dehydration grade 2
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dehydration grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Depression grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Diarrhea grade 1
|
10 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Diarrhea grade 2
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Diarrhea grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dizziness grade 1
|
8 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dry mouth grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dry skin grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dysgeusia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dysgeusia grade 2
|
4 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Dyspnea grade 1
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Ear and labyrinth disorders-Other, specify grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Edema limbs grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Edema limbs grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
EKG QT corrected interval prolong grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
EKG QT corrected interval prolong grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
EKG QT corrected interval prolong grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Eye disorders - Other, specify grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Fatigue grade 1
|
6 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Fatigue grade 2
|
7 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Fatigue grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Fever grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Flank pain grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Flu like symptoms grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Flushing grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Gastroesophageal reflux disease grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Gastroesophageal reflux disease grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Gastrointestinal disorders -Other, specify grade 1
|
7 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Generalized muscle weakness grade 1
|
5 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Generalized muscle weakness grade 2
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Headache grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hearing impaired grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Heart failure grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hematuria grade 1
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hematuria grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hoarseness grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hot flashes grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hyperglycemia grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hyperglycemia grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hyperglycemia grade 3
|
10 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hyperkalemia grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypertension grade 2
|
5 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypertension grade 3
|
5 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypertriglyceridemia grade 1
|
3 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypertriglyceridemia grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypoalbuminemia grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypocalcemia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypocalcemia grade 3
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypokalemia grade 2
|
2 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypomagnesemia grade 1
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hypomagnesemia grade 2
|
1 Participants
|
|
The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
Hyponatremia grade 3
|
4 Participants
|
SECONDARY outcome
Timeframe: Every 12 weeks for the first 36 weeks and then every 16 weeks thereafter up to 100 weeksPercentage of participants responding to treatment by measurements of tumor using Response Evaluation Criteria In Solid Tumors (RECISTv1.0) 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; Overall Response (OR) = CR + PR, before and after treatment with the combination of pasireotide in combination with docetaxel
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel
|
44.4 percentage of participants
Interval 27.2 to 63.1
|
SECONDARY outcome
Timeframe: On days 1, 22, 43Percentage change of prostate-specific antigen (PSA) decline or increase noted
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Percentage Prostate-specific Antigen (PSA) Change Noted
from day 1 to day 22
|
-18.52 percentage change of PSA from day 1
Interval -70.97 to 147.4
|
|
Percentage Prostate-specific Antigen (PSA) Change Noted
from day 1 to day 43
|
-31.49 percentage change of PSA from day 1
Interval -88.14 to 88.89
|
SECONDARY outcome
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study, up to 2 yearsTime from Treatment start date to Progression (TTP) Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Time to Progression (TTP)
|
7.2 months
Interval 3.8 to 8.2
|
SECONDARY outcome
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on studyTime from Treatment start date to date of death or last follow-up.
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Overall Survival (OS)
|
18.3 months
Interval 15.0 to 29.7
|
SECONDARY outcome
Timeframe: Predosing/end of infusion/2, 3, 4 ,7, 24 and 48 hours after start of docetaxel; Day 43; predosing for docetaxel and pasireotide/end of infusion/2, 3, 4, 7, 24 hours day 44/48 hours day 45 after start of infusion; days 29, 57, and 85 prior to pasireotidePharmacokinetics (PK) of SOM230 measured in the bloodstream (in ng/ml) at days 29, 57, and 85.
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Pharmacokinetics (PK) of SOM230
Level at day 29
|
15.4 ng/ml
Interval 4.75 to 46.1
|
|
Pharmacokinetics (PK) of SOM230
Level at day 57
|
14.9 ng/ml
Interval 5.15 to 34.2
|
|
Pharmacokinetics (PK) of SOM230
Level at day 85
|
14.5 ng/ml
Interval 3.38 to 35.2
|
SECONDARY outcome
Timeframe: Baseline and days 22 and 43Measurement of levels of IGF-1, serum chromogranin A (SCA), and neuron specific enolase (NSE), the change between time points (day 22 and day 43) from day 1 as measured in percent change.
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
IGF-1 day 1 to day 22
|
-47.74 percent change of biomarker from day 1
Interval -81.67 to 420.0
|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
IGF-1 day 1 to day 43
|
-65.64 percent change of biomarker from day 1
Interval -76.85 to 9200.0
|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
SCA day 1 to day 22
|
-25.36 percent change of biomarker from day 1
Interval -82.17 to 76.09
|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
SCA day 1 to day 43
|
-21.43 percent change of biomarker from day 1
Interval -92.21 to 173.91
|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
NSE day 1 to day 22
|
-17.00 percent change of biomarker from day 1
Interval -82.32 to 294.44
|
|
Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
NSE day 1 to day 43
|
8.00 percent change of biomarker from day 1
Interval -70.12 to 61.11
|
SECONDARY outcome
Timeframe: Baseline and days 22 and 43Measurements of CTC counts, the change between time-points (day 22 and day 43) from day 1 as measured in percent change.
Outcome measures
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 Participants
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy
CTC from day 1 to day 22
|
-5.50 percent change of CTC from day 1
Interval -1424.0 to 93.0
|
|
Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy
CTC from day 1 to day 43
|
-29.50 percent change of CTC from day 1
Interval -1446.0 to 19.0
|
Adverse Events
Treatment (Chemotherapy, Receptor Agonist)
Serious events: 14 serious events
Other events: 18 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 participants at risk
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Gastrointestinal disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Blood and lymphatic system disorders
Edema limbs
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Blood and lymphatic system disorders
Hematoma
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
General disorders
Syncope
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Renal and urinary disorders
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Receptor Agonist)
n=18 participants at risk
Patients receive pasireotide IM on day 1, docetaxel IV over 1 hour, and prednisone PO BID continuously. Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
pasireotide: Given IM
prednisone: Given PO
|
|---|---|
|
General disorders
Fatigue
|
94.4%
17/18 • Number of events 35 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
72.2%
13/18 • Number of events 17 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
77.8%
14/18 • Number of events 40 • Any All-Cause Mortality, Serious, or Other (Not Including Serious) adverse event occurring after the patient has provided informed consent and until 4 weeks after the patient has stopped study participation must be reported, an average of 2 years.
These will be followed per IND requirements (if applicable) as well as per sponsor requirements and WSU IRB requirements.
|
Additional Information
Ulka N. Vaishampayan
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place