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

NCT00848601 | Terminated Phase 1

• 1 other identifier: SGI-1776-01
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 3

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.

Conditions

Prostate Cancer; Non-Hodgkins Lymphoma

Keywords

SGI-1776; PIM; Hormone & Docetaxel refractory Prostate Cancer; Refractory non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• MTD & DLT

  July 2011

Secondary Outcomes (1)

• Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation.

  July 2011

Interventions

SGI-1776 DRUG

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

Eligibility Criteria

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

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

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (3)

UCLA

Los Angeles, California, 90095-1678, United States

Location

Cancer Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphoma, Non-Hodgkin

Interventions

SGI 1776

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

GB (1); US (2)