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Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Hormone and Docetaxel Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Non-Hodgkins Lymphoma

Thank you

Trial Information

Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Hormone and Docetaxel Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma


General

Inclusion Criteria:



1. Read, understand and sign the IRB- or IEC-approved ICF confirming his or her
willingness to participate in this trial.

2. At least 18 years old.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

4. Adequate bone marrow function; normal renal and hepatic function, normal cardiac
function.

5. Normal cardiac function in the opinion of the investigator and supported by LVEF 50%
or greater on the screening echocardiogram (or MUGA), no significant abnormalities on
the screening ECG (eg, left bundle branch block, III degree AV block, acute
myocardial infarction, Wolff-Parkinson-White syndrome or QTc interval ≥ 450 msec) and
no history of additional risk factors for torsades de pointes (eg, heart failure,
hypokalemia or family history of Long QT Syndrome).

Exclusion Criteria:

1. Active secondary malignancy or history of other malignancy within the last two years
except non-melanoma skin cancers or cervical carcinoma in situ.

2. History of significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure and/or myocardial infarction or any Class 3 or
4 cardiac disease as defined by the New York Heart Association Functional
Classification.

3. Received any anticancer agent(s) within the past 3 weeks, including investigational
agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic
or marketed or investigational tyrosine kinase inhibitors.

4. Received prior radiation therapy within the past 4 weeks or received irradiation of ≥
25% of their bone marrow reserve.

5. Any serious, uncontrolled active infection that requires systemic treatment or known
infection with HIV, HCV or HBV.

6. Symptomatic CNS metastases or lesions for which treatment is required.

Prostate Cancer

Inclusion Criteria:



1. Males with histologically confirmed adenocarcinoma of the prostate, which is now
metastatic (e.g., any T, any N, M1a-c)based on bone scan, CT scan, or MRI scan.
Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.

2. Demonstrated evidence of progressive disease despite androgen deprivation (androgen
ablation or surgical castration), anti-androgen withdrawal and progression of disease
after docetaxel-based therapy.

• Greater than 25% increase in 3 consecutive tests (PSA 1 < PSA 2 < PSA 3),
each PSA value separated by at least 1 week

3. Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on
continuous or intermittent medical androgen suppression with a LHRH agonist or
antagonist.

4. At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide;
and at least 6 weeks since prior bicalutamide or nilutamide.

5. Systemic corticosteroids discontinued within two weeks of dosing, except low dose
regimens which may continue if unchanged

6. Strontium-89 or Samarium-153 must have been completed at least 8 weeks prior to the
first dose of therapy and recovered from all treatment-related toxicities.

Exclusion Criteria:

1. Must not be receiving concurrent anti-androgen hormonal therapy for hormone
refractory prostate cancer.

Non-Hodgkin's Lymphoma

Inclusion Criteria:



1. Histologically proven relapsed or refractory non-Hodgkin's lymphoma subjects for
which there is no available standard therapy or therapy which may provide clinical
benefit.

2. Measurable disease (at least 1 lesion ≥ 1.5 cm).

Exclusion Criteria:

1. Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter.

2. Systemic corticosteroids within 2 weeks, except low dose regimens which may continue
if unchanged.

3. Received any radiopharmaceutical therapy within the past six weeks.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

MTD & DLT

Outcome Time Frame:

July 2011

Safety Issue:

Yes

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

SGI-1776-01

NCT ID:

NCT00848601

Start Date:

February 2009

Completion Date:

October 2010

Related Keywords:

  • Prostate Cancer
  • Non-Hodgkins Lymphoma
  • SGI-1776
  • PIM
  • Hormone & Docetaxel refractory Prostate Cancer
  • Refractory non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Prostatic Neoplasms

Name

Location

Cancer Therapy Research CenterSan Antonio, Texas  78229
UCLALos Angeles, California  90095