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An Open Label Phase II Study Evaluating the Safety and Efficacy of CPTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Tumors

Thank you

Trial Information

An Open Label Phase II Study Evaluating the Safety and Efficacy of CPTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms

Inclusion Criteria


Inclusion:

- Biopsy-proven metastatic neuroendocrine tumors and biochemical evidence of disease

- Evidence of progressive disease with measurable lesion(s) or inadequate controlled
disease syndrome.

- Receiving Sandostatin LAR 30 mg q 4 weeks

- Age equal to or greater than 18 years

- Karnofsky Performance Status equal to or greater than 60

- Lab values within 2 weeks prior to randomization:

- Absolute Neutrophil Count equal to or greater than 1.5 x 109/L

- Platelets equal to or greater than 100 x 109/L

- Hemoglobin equal to or greater than 9 g/dL

- Serum creatinine & bilirubin equal to or less than 1.5 ULN

- AST & ALT equal to or less than 3.0 x ULN equal to or less than 5 x ULN if liver
metastases present

- Negative for proteinuria based on dip stick reading OR, if documentation of +1
result for protein on dip stick reading, then total urinary protein equal to or
less than 500 mg and measured creatinine clearance equal to or greater than 50
mL/min from a 24-hour urine collection

- Life expectancy 12 weeks or more

- Written informed consent obtained according to local guidelines

Exclusion:

- Previous radiolabeled somatostatin analog therapy within 6 months

- Hepatic artery embolization within 6 months (1 month if there are other sites of
measurable disease)

- Cryoablation of hepatic metastasis within 2 months

- History or presence of CNS disease

- History of another primary malignancy equal to or less than 5 years, with the
exception of inactive basal or squamous cell carcinoma of the skin

- Prior chemotherapy within 3 weeks prior to randomization.

- Prior biologic or immunotherapy within 2 weeks prior to randomization.

- Prior full field radiotherapy or major surgery within 4 weeks or limited field
radiotherapy within 2 weeks prior to randomization.

- Must have recovered from all therapy-related toxicities.

- Minor surgery within 2 weeks prior to randomization.

- Any investigational drugs within 4 weeks prior to randomization

- Prior therapy with anti-VEGF agents

- Pleural effusion or ascites that causes respiratory compromise equal to or greater
than CTC grade 2 dyspnea

- Female patients who are pregnant or breast feeding or adults of reproductive
potential not employing an effective method of birth control. Women of childbearing
potential must have a negative serum pregnancy test 48 hours prior to study
treatment.

- Any of the following concurrent severe and/or uncontrolled medical conditions which
could compromise participation in the study:

- Uncontrolled high blood pressure, history of labile hypertension, or history of
poor compliance with an antihypertensive regimen

- Unstable angina pectoris

- Symptomatic congestive heart failure

- Myocardial infarction within 6 months prior to randomization

- Active or uncontrolled infection

- Interstitial pneumonia or extensive & symptomatic interstitial fibrosis of the
lung

- Chronic renal disease

- Subjects at risk of significant cardiac arrhythmias

- Uncontrolled diabetes

- Acute or chronic liver disease

- Impairment of gastrointestinal function or GI disease that may significantly
alter the absorption of PTK787/ZK 222584

- A confirmed diagnosis of human immunodeficiency virus infection are excluded at the
investigator's discretion

- If you are taking therapeutic warfarin sodium or similar oral anticoagulants. Heparin
is allowed.

- If you are unwilling to or unable to comply with the protocol

- If you have symptomatic gallstones

- If you have received glucocorticoid therapy within 6 months, or who are currently
receiving any chemotherapeutic agents, insulin sensitizers, or exogenous growth
hormones

- If you have unacceptable concomitant diagnoses, or who have received medication
and/or therapies that would place the patient at increase risk, or would in the
opinion of the investigator, interfere with the evaluation of efficacy and safety

- If you exhibit symptoms indicative of intolerance of Sandostatin LAR

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the efficacy of PTK787/ZK 222584 in subjects with metastatic neuroendocrine tumors that have evidence of progressive disease or an increase in disease related syndrome symptoms as evidence by changes in biochemical markers.

Outcome Time Frame:

Until disease progression

Safety Issue:

Yes

Principal Investigator

Thomas M O'Dorisio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Food and Drug Administration

Study ID:

CPTK787/ZK222584

NCT ID:

NCT00627198

Start Date:

December 2006

Completion Date:

November 2010

Related Keywords:

  • Neuroendocrine Tumors
  • Metastatic; neuroendocrine tumor; clinical trial
  • Neuroendocrine Tumors

Name

Location

University of IowaIowa City, Iowa  52242