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

Stopped early · Phase 1

Conditions studied: Prostate Cancer, Non-Hodgkins Lymphoma

In brief

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.

Key facts

Study ID

NCT00848601

Run by

Astex Pharmaceuticals, Inc.

People needed

14

Starts

2009-02-01

Expected to finish

2010-10-01

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Read, understand and sign the IRB- or IEC-approved ICF confirming his or her willingness to participate in this trial.
• At least 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.
• 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).

You may not qualify if…

• Active secondary malignancy or history of other malignancy within the last two years except non-melanoma skin cancers or cervical carcinoma in situ.
• 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.
• 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.
• Received prior radiation therapy within the past 4 weeks or received irradiation of ≥ 25% of their bone marrow reserve.
• Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
• Symptomatic CNS metastases or lesions for which treatment is required.
• Prostate Cancer
• Inclusion Criteria:
• 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.
• 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
• Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
• At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide; and at least 6 weeks since prior bicalutamide or nilutamide.
• Systemic corticosteroids discontinued within two weeks of dosing, except low dose regimens which may continue if unchanged
• 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:
• Must not be receiving concurrent anti-androgen hormonal therapy for hormone refractory prostate cancer.
• Non-Hodgkin's Lymphoma
• Inclusion Criteria:
• 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.
• Measurable disease (at least 1 lesion ≥ 1.5 cm).
• Exclusion Criteria:
• Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter.
• Systemic corticosteroids within 2 weeks, except low dose regimens which may continue if unchanged.
• Received any radiopharmaceutical therapy within the past six weeks.

Where it is running

• UCLA — Los Angeles, California, United States
• Cancer Therapy Research Center — San Antonio, Texas, United States
• Royal Marsden Hospital — Sutton, England, United Kingdom

Full record on ClinicalTrials.gov

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