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

• Register: EUCTR
• Last refreshed on: 5 November 2012
• Main ID: EUCTR2004-005068-26-DK
• Date of registration: 14/03/2005
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company limited
• Public title: A Phase 2 Study of Oral Enzastaurin HCl in Patients with Metastatic Colorectal Cancer - N/A
• Scientific title: A Phase 2 Study of Oral Enzastaurin HCl in Patients with Metastatic Colorectal Cancer - N/A
• Date of first enrolment: 27/04/2005
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005068-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Denmark, Sweden

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

metastatic colorectal cancer

Intervention(s)

Product Name: Enzastaurin
Product Code: LY317615
Pharmaceutical Form: Tablet
INN or Proposed INN: Enzastaurin Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: Main objective :To estimate the 6-month (24 weeks) progression-free survival for patients with metastatic CRC who are treated with enzastaurin.

Primary end point(s): Progression Free survival estimate at 6 months is the primary efficacy endpoint.

Progression-free survival is defined as the time from the date of the first enzastaurin dose to the first date of documented progressive disease or death due to any cause, whichever occurs first. Progression-free survival will be censored at the date of the last assessment visit for patients who are still alive and who have not had documented progressive disease.

Secondary Objective: Secondary objectives :·
To estimate the objective response rate (complete response [CR] plus partial response [PR]) on enzastaurin therapy·
To estimate time-to-event efficacy measures, including overall survival, progression-free survival, duration of stable disease, time-to-response for responding patients, and duration of response for responding patients·
To evaluate the safety of enzastaurin in this patient population·
To evaluate the pharmacokinetics in this patient population using sparse sampling·
To evaluate carcinoembryonic antigen (CEA) response in patients receiving enzastaurin·
To gather preliminary data on patient-reported outcomes (symptoms, functioning, and quality of life) and evaluate responsiveness of the validated questionnaire for future clinical trials·
To evaluate VEGF levels in patients receiving enzastaurin.

Secondary ID(s)

2004-005068-26-SE

H6Q-MC-JCAR(b)