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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Prostate Cancer
  • Non-Hodgkins Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT00848601
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Study Type
Interventional
Intervention
Drug : SGI-1776
Intervention Type
See Interventions above
Primary Outcome Measures
  • MTD & DLT; July 2011
Secondary Outcome Measures
  • Response rate, pharmacokinetics, PSA response, renal elimination and pharmacodynamic effects on biomarker modulation.; July 2011
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Research Site
Sutton
Surrey
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
SGI-1776-01
Sponsor(s)
Astex Pharmaceuticals
Key Dates

Recruitment Start Date

Feb 2009

Recruitment End Date

Oct 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

19 Feb 2009

Last Updated

01 Dec 2011