A Phase 2 Study of Oral Enzastaurin HCl in Patients with Metastatic Colorectal Cancer - N/A

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

criteria:
[1]Have histologically or cytologically documented adenocarcinoma of the colon or rectum.
[2]Have Stage 4 disease that is not amenable to regimens with curative intent (including surgery and chemotherapy).
[3]Have not received prior systemic chemotherapy for advanced CRC (prior adjuvant therapy is allowed).
[4]Have given written informed consent.
[5]Have the presence of at least one measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) (refer to Protocol Attachment JCAR.4).
[6]Have a performance status of 0 to 1 on the ECOG Scale and no physical tumor symptoms (refer to Protocol Attachment JCAR.2).
[7]Have completed all previous radiation therapy and surgical procedures for cancer at least 30 days prior to study entry and recovered from all effects of these therapies.
[8]Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
[9]Have adequate bone marrow reserve and organ function as follows:?Neutrophil count to > 1.0 x 109/L and platelets > 100 x 109/L.·Hepatic: total bilirubin <1.2 times ULN; alkaline phosphatase <1.5 times ULN; alanine transaminase (ALT) and aspartate transaminase (AST) <2.0 times ULN (or <3.0 times ULN in case of known liver involvement). LDH must be <1.5 times ULN.
[10]Reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
[11]Are at least 19 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[12]Have physical tumor symptoms
[13]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[14]Have evidence of central nervous system metastasis (routine screening is not necessary).
[15]Women who are pregnant or breastfeeding.
[16]Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
[17]Second primary malignancy that could affect compliance with the protocol or interpretation of the results. Patients with adequately treated basal cell carcinoma of the skin or who have had another malignancy in the past, but have been disease-free for more than 2 years, are eligible.
[18]Electrocardiogram (ECG) abnormalities indicative of cardiac disease (at the discretion of the investigator).
[19]Uncorrected electrolyte disorder, including potassium <3.4 mmol/L (<3.4 mEq/L).
[20] Inability to swallow tablets.
[21] Are currently receiving phenytoin, phenobarbital or carbamazapine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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