Trial Outcomes & Findings for Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (NCT NCT00414388)

Last Updated: 2014-04-07

Results Overview

The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

participants were followed for an average of 25 months

Results posted on

2014-04-07

Participant Flow

Recruitment was from our clinic population.

Eligible patients were those who progressed while receiving chemotherapy (docetaxel or mitoxantrone)or within 12 weeks of stopping chemo.

Participant milestones

Participant milestones
Measure	Single Agent Sorafenib Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m\^2 and mitoxantrone was given at 12 mg/m\^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Agent Sorafenib Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m\^2 and mitoxantrone was given at 12 mg/m\^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
Overall Study Adverse Event	1

Baseline Characteristics

Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Agent Sorafenib n=22 Participants Oral Single agent Sorafenib 400mg twice daily
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	17 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Region of Enrollment United States	22 participants n=99 Participants

PRIMARY outcome

Timeframe: participants were followed for an average of 25 months

Population: 15 patients required dose reductions.

The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%

Outcome measures

Outcome measures
Measure	Single Agent Sorafenib n=21 Participants Oral Single agent Sorafenib 400mg twice daily
Percentage of Patients Needing a Dose Reduction.	71 percentage of participants Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 3-10 months

Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.

Outcome measures

Outcome measures
Measure	Single Agent Sorafenib n=21 Participants Oral Single agent Sorafenib 400mg twice daily
Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).	76 percentage of patients Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 1-10 months

PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (\<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.

Outcome measures

Outcome measures
Measure	Single Agent Sorafenib n=21 Participants Oral Single agent Sorafenib 400mg twice daily
PSA -Biochemical Response	45 percentage of participants

Adverse Events

Single Agent Sorafenib

Serious events: 12 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Agent Sorafenib n=22 participants at risk Oral Single agent Sorafenib 400mg twice daily
Renal and urinary disorders urinary retention	9.1% 2/22
Blood and lymphatic system disorders Anemia	4.5% 1/22
General disorders Hypoglycemia	4.5% 1/22
Gastrointestinal disorders constipation	9.1% 2/22
General disorders Back Pain	4.5% 1/22
Blood and lymphatic system disorders Electrolyte imbalance	4.5% 1/22
General disorders Fatigue	4.5% 1/22
Gastrointestinal disorders Dehydration	4.5% 1/22
General disorders Adominal Pain	9.1% 2/22
Respiratory, thoracic and mediastinal disorders Pneumonia	9.1% 2/22
Renal and urinary disorders Urinary Tract Infection	4.5% 1/22
Cardiac disorders Atrial Fibrillation	4.5% 1/22
Gastrointestinal disorders C-diff	4.5% 1/22
Blood and lymphatic system disorders Neutropenic Fever	4.5% 1/22
Blood and lymphatic system disorders Diverticular Bleed	4.5% 1/22

Other adverse events

Other adverse events
Measure	Single Agent Sorafenib n=22 participants at risk Oral Single agent Sorafenib 400mg twice daily
General disorders Fatigue	72.7% 16/22
Skin and subcutaneous tissue disorders hand/foot syndrome	45.5% 10/22
General disorders Hypoglycemia	9.1% 2/22
General disorders Hyperglycemia	45.5% 10/22
Blood and lymphatic system disorders Leukopenia	63.6% 14/22
Blood and lymphatic system disorders Neutropenia	40.9% 9/22
Blood and lymphatic system disorders Thrombocytopenia	77.3% 17/22
Blood and lymphatic system disorders Anemia	77.3% 17/22
Blood and lymphatic system disorders Lymphopenia	86.4% 19/22
Blood and lymphatic system disorders Hypocalcemia	50.0% 11/22
General disorders Alopecia	54.5% 12/22
Gastrointestinal disorders Anorexia	68.2% 15/22
Gastrointestinal disorders Albumin decreased	68.2% 15/22
Gastrointestinal disorders AST increased	27.3% 6/22
Gastrointestinal disorders Alkaline Phosphatase Increased	50.0% 11/22
Psychiatric disorders Anxiety	18.2% 4/22
Nervous system disorders Arthralgia	13.6% 3/22
Cardiac disorders Atrial Fibrillation	9.1% 2/22
Blood and lymphatic system disorders Bruises Easily	36.4% 8/22
Renal and urinary disorders Bilirubin Increased	13.6% 3/22
General disorders Back Pain	9.1% 2/22
General disorders Chills	22.7% 5/22
Respiratory, thoracic and mediastinal disorders Cough	36.4% 8/22
General disorders Concentration Difficulty	18.2% 4/22
Gastrointestinal disorders Constipation	36.4% 8/22
Renal and urinary disorders Creatinine Increased	13.6% 3/22
Musculoskeletal and connective tissue disorders Chest pain non cardiac	13.6% 3/22
Gastrointestinal disorders Dehydration	18.2% 4/22
Gastrointestinal disorders Diarrhea	81.8% 18/22
General disorders Dizziness	22.7% 5/22
Psychiatric disorders Depression	22.7% 5/22
Respiratory, thoracic and mediastinal disorders Dyspnea on Exertion	13.6% 3/22
Ear and labyrinth disorders Ear Pain	13.6% 3/22
Eye disorders Eyes dry	13.6% 3/22
General disorders Edema	18.2% 4/22
Eye disorders Eyes tearing	13.6% 3/22
General disorders Fall	9.1% 2/22
General disorders Fever	18.2% 4/22
General disorders Foot pain	9.1% 2/22
General disorders Facial swelling	9.1% 2/22
Gastrointestinal disorders Globulin decreased	27.3% 6/22
Reproductive system and breast disorders Gynecomastia	13.6% 3/22
Ear and labyrinth disorders Hard of hearing	13.6% 3/22
General disorders Hypotension	9.1% 2/22
Gastrointestinal disorders Hypokalemia	36.4% 8/22
General disorders Headache	31.8% 7/22
Gastrointestinal disorders Heartburn	9.1% 2/22
General disorders Hypertension	9.1% 2/22
Gastrointestinal disorders Hyponatremia	36.4% 8/22
Reproductive system and breast disorders Hot flashes	9.1% 2/22
Gastrointestinal disorders Hyperkalemia	18.2% 4/22
Skin and subcutaneous tissue disorders Itching	22.7% 5/22
General disorders Insomnia	13.6% 3/22
Musculoskeletal and connective tissue disorders Jaw Pain	22.7% 5/22
Reproductive system and breast disorders Libido decreased	13.6% 3/22
Gastrointestinal disorders Mouth Dry	50.0% 11/22
Gastrointestinal disorders Mouth Sores	9.1% 2/22
Gastrointestinal disorders Nausea	36.4% 8/22
General disorders Neuropathy	63.6% 14/22
Skin and subcutaneous tissue disorders Nail changes	31.8% 7/22
Gastrointestinal disorders Protein Decreased	63.6% 14/22
General disorders Pain	31.8% 7/22
Infections and infestations Pneumonia	13.6% 3/22
Skin and subcutaneous tissue disorders Rash	68.2% 15/22
Respiratory, thoracic and mediastinal disorders Shortness of Breath	18.2% 4/22
Skin and subcutaneous tissue disorders Skin peeling	9.1% 2/22
General disorders Sweats	13.6% 3/22
Gastrointestinal disorders Stomatitis	13.6% 3/22
Cardiac disorders Tachycardia	40.9% 9/22
Gastrointestinal disorders Taste Changes	31.8% 7/22
Gastrointestinal disorders Throat sore	40.9% 9/22
Renal and urinary disorders Urinary retention	9.1% 2/22
Skin and subcutaneous tissue disorders Ulcer pressure	13.6% 3/22
Renal and urinary disorders Urination Problems	13.6% 3/22
Gastrointestinal disorders Vomiting	9.1% 2/22
Eye disorders Vision Problems	18.2% 4/22
General disorders Weight decreased	36.4% 8/22
Respiratory, thoracic and mediastinal disorders Wheezing	13.6% 3/22

Additional Information

Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD (PI)

Oncology Specialists, S.C.

Phone: 847-268-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place