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Safety of SGI-1776, A PIM Kinase Inhibitor in Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00848601
Recruitment Status : Terminated (The dose limiting toxicity of cardiac QTc prolongation was identifiedin the phase 1 study in patients with refractory prostate and lymphoma)
First Posted : February 20, 2009
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide clinical benefit is available will be enrolled. Primary objectives: estimate the maximum tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate, pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal elimination.

Condition or disease Intervention/treatment Phase
Prostate Cancer Non-Hodgkins Lymphoma Drug: SGI-1776 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : February 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: SGI-1776
    Starting dose 100 mg (total daily dose) administer as 50 mg every 12 hours for 14 days of a 21-day cycle, dose escalation in successive cohorts until progression or toxicity develops

Outcome Measures

Primary Outcome Measures :
  1. MTD & DLT [ Time Frame: July 2011 ]

Secondary Outcome Measures :
  1. Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation. [ Time Frame: July 2011 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848601

United States, California
Los Angeles, California, United States, 90095-1678
United States, Texas
Cancer Therapy Research Center
San Antonio, Texas, United States, 78229
United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astex Pharmaceuticals
More Information

Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00848601     History of Changes
Other Study ID Numbers: SGI-1776-01
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by Astex Pharmaceuticals:
Hormone & Docetaxel refractory Prostate Cancer
Refractory non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action