Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)

NCT00424385 | Completed Phase 1 Results

• 1 other identifier: CST1571BUS260 (0617)
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached without toxicity, the study will close for accrual. If toxicity is noted prior to reaching the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design will be the one used for any future phase II study.

Conditions

Prostate Cancer

Keywords

AIPC, Prostate cancer; prostate

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Dose Limiting Toxicities (DLT's)

  Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.

  up to 20 weeks

Secondary Outcomes (2)

• Overall Clinical Benefit

  up to 20 weeks

• Time to Disease Progression (TTP)

  up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug

Study Arms (1)

Arm 1

EXPERIMENTAL

Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib

Drug: Gleevec + Sorafenib

Interventions

Gleevec + Sorafenib DRUG

400 mg Sorafenib every day (QD) 300mg Gleevec QD

Also known as: Imatinib mesylate; Nexavar

Arm 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older.
• Histologically documented diagnosis of Prostate Cancer regardless of Gleason score.
• Androgen-Independent Prostate Cancer
• At least one measurable site of disease
• Patients must have failed one or more lines of systemic chemotherapy, regardless of the chemotherapeutic agent used. There is NO limit to how many lines of chemotherapy a patient can receive
• Patients receiving anti-coagulation treatment with an agent such as heparin may be allowed to participate. Patients on Warfarin are NOT allowed to participate.
• Last chemotherapy exposure 4 weeks prior to study entry
• Prior exposure to Sorafenib is allowed as long as last Sorafenib dose was 3 weeks or more from study entry
• Progression after chemotherapy can be demonstrated radiographically (as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria) or biochemically with prostate-specific antigen (PSA) being elevated more than 25% than previous value as long as a repeat PSA confirms progression. (repeat PSA should be done within 3 weeks from the last one). Patients with bone-only disease are considered progressing if there are two more lesions on a new bone scan.
• Performance status 0,1, 2 (ECOG)
• Adequate end organ function, defined as the following:
• total bilirubin \< 1.5 x Upper Limit of Normal (ULN), serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x Upper Limit of Normal (UNL), creatinine \< 1.5 x Upper Limit of Normal (ULN), absolute neutrophil count (ANC) \> 1.0 x 109/L, platelets \> 75 x 109/L.
• Men of childbearing potential must agree to employ an effective barrier method of birth control prior to the study entry, throughout the duration of the study and for up to 3 months following discontinuation of study drug.
• Written, voluntary informed consent.
• Patients are allowed the following concurrent therapies:

You may not qualify if:

• Patient has received any other investigational agents within 21 days of first day of study drug dosing, unless the disease is rapidly progressing.
• Patient is \< 3 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal or squamous cell skin cancer. Existence of any other malignant disease is not allowed.
• Patient with Grade III/IV cardiac problems
• Patient has a severe and/or uncontrolled medical disease
• Patient has a known brain metastasis.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event \> Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Use of St. John's Wort or rifampin (rifampicin).
• Any condition that impairs patient's ability to swallow whole pills.
• Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient previously received radiotherapy to ³ 25 % of the bone marrow

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead

Study Sites (2)

Oncology Specialists, S.C

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Imatinib Mesylate; Sorafenib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Phenylurea Compounds; Urea; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Sigrun Hallmeyer, MD Director of Research; Chadi Nabhan, MD FACP (PI)
• Organization: Oncology Specialists, SC

shallmeyer@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 21, 2014
• Results First Posted: July 21, 2014

Record last verified: 2014-06

Locations

US (2)