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Prostate CancerPhase 1NCT00424385

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

A Phase 1 study testing Gleevec + Sorafenib in people with Prostate Cancer, run by Oncology Specialists, S.C. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Gleevec + Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesUnited States
Study dates
Jan 2007to Feb 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Prior exposure to Gleevec is an EXCLUSION
  • 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:
  • Intravenous bisphosphonates if administered for bone metastases
  • luteinizing hormone releasing hormone (LHRH) analogues
  • Narcotic-type medical interventions to control malignancy-related pain

Who cannot join

  • 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.
Show all 17Show fewer
  • 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
  • Patient had a major surgery within 2 weeks prior to study entry.
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oncology Specialists, S.C

    Niles, Illinois, 60714

  • Oncology Specialists, S.C

    Park Ridge, Illinois, 60068

Other trials in United States

About this study

Official title: Phase I Study Investigating the Safety and Feasibility of Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-Independent Chemotherapy-Failure Prostate Cancer.

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.

Read the detailed description

Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer (AIPC) and the fact that both agents can be given orally with what appears to be tolerable side effects, we hypothesize that combining both agents may provide patients with another effective regimen in a disease where therapeutic options are limited. This study is designed to investigate the safety of combining Gleevec and Sorafenib as well as feasibility in AIPC patients who have failed one or more lines of systemic chemotherapy. Once safety is established, a follow-up phase II study will commence to investigate efficacy.

Conditions
Prostate Cancer
Being tested
Gleevec + Sorafenib
Keywords
AIPC, Prostate cancer, prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gleevec + SorafenibDrug

    Also called Imatinib mesylate; Nexavar

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

Study groups in NCT00424385
Study groupRoleWhat they receive
Arm 1ExperimentalOnly 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
Receives: Drug: Gleevec + Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 20 weeks

Secondary outcomes (2)

  1. Overall Clinical Benefit

    Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).

    Measured: up to 20 weeks

  2. Time to Disease Progression (TTP)

    Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424385
Sponsor's protocol ID
CST1571BUS260 (0617)
Status last verified
Jun 2014
First submitted
17 Jan 2007
Last updated
21 Jul 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gleevec + Sorafenib in people with Prostate Cancer, run by Oncology Specialists, S.C. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Experiencing Dose Limiting Toxicities (DLT's) (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.

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