Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with DoseOptimization of Two Different Schedules of Elisidepsin Trifluoroacetate(Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced orMetastatic Esophageal, Esophagogastric Junction or Gastric Cancer AfterFailure of One but not More than Two Prior Lines of Systemic Therapy - IMAGE

Active, not recruiting

• Conditions: ocally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer; MedDRA version: 12.1Level: LLTClassification code 10056267Term: Gastroesophageal cancer

• Registration Number: EUCTR2010-020325-40-GB
• Lead Sponsor: Pharma Mar, S.A. Sociedad Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-19
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Age = 18 years.
2. Eastern Cooperative Oncology Group (ECOG) PS of = 1 (see Appendix 1).
3. Life expectancy = 3 months.
4. Patients with histologically/cytologically confirmed diagnosis of locally advanced
(unresectable) or metastatic esophageal, esophagogastric junction or gastric cancer.
Patients must have received one but not more than two prior lines of systemic
therapy and must be progressing after last prior therapy before study entry.
5. Adequate bone marrow, renal, hepatic, and metabolic function (assessed = 7 days
before first study drug administration):
a) Platelet count = 100 x 109/l, hemoglobin = 8.5 g/dl and absolute neutrophil count (ANC) = 1.0 x 109/l.
b) Aspartate aminotransferase (AST) and ALT = 3.0 x upper limit of normal (ULN), independently of the presence of liver metastases.
c) Direct bilirubin = ULN and total bilirubin = 1.5 x ULN.
d) International Normalized Ratio (INR) = 1.5 (except if ongoing oral anticoagulation therapy).
e) Renal function: patients with calculated creatinine clearance (using Cockcroft
and Gault’s formula, see Appendix 3) = 30 ml/min.
f) Albumin = 2.5 g/dl.
6. Recovery to grade = 1 from any AE derived from any previous anticancer treatment
(excluding alopecia and grade 2 non-painful peripheral neuropathy).
7. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after
discontinuation of treatment. Acceptable methods of contraception include
complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal
implant and double barrier (condom with a contraceptive sponge or contraceptive
suppository).
8. Voluntarily signed and dated written informed consent, obtained from the patient
prior to any specific study procedure.
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

1. Concomitant diseases/conditions:
a) Clinically relevant non-neoplastic liver disease [i.e., cirrhosis; active chronic
hepatitis, hepatitis C virus (HCV)/hepatitis B virus (HBV) infection].
b) History or presence of unstable angina, myocardial infarction, clinically relevant valvular heart disease, treatment-requiring and/or symptomatic arrhythmia or congestive heart failure within the last six months prior to enrollment.
c) Active uncontrolled infection.
d) Known human immunodeficiency virus infection (HIV1/2).
e) Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
f) Parenteral nutritional support = 25% of total daily caloric requirements.
g) Any other major illness that, in the Investigator’s or the Sponsor’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
h) Painful peripheral neuropathy = grade 2.
i) Any ongoing cancer-related coagulopathy disorder [other than medically treated deep venous thrombosis (DVT) during at least one month].
2. Known central nervous system (CNS) metastatic involvement.
3. Malignant or non-malignant ascitis = grade 3.
4. Primary histology other than squamous-cell carcinoma or adenocarcinoma.
5. Prior treatment with elisidepsin or KF.
6. Less than 50 kg of body weight (only for patients included in the dose optimization
phase).
7. Men or women of childbearing potential who are not using an effective method of
contraception as previously described; women who are pregnant or breast feeding.
8. High transfusional requirements (> 4 packages of red blood cells and/or one platelet transfusion) in the last four weeks prior to study entry.
9. Participation in another clinical trial or concomitant treatment with any investigational product in the 4-week period prior to study entry.
10. Patients with a prior invasive malignancy (except non-melanoma skin cancer) who
have had any evidence of disease within the last three years.
11. Major surgery performed or planned within four weeks of the start of study treatment (line placement is not considered major surgery).
12. Patients with serious non-healing wound or ulcer. This includes history of abdominal fistula, gastrointestinal perforation, active uncontrolled bleeding or intraabdominal abscess during the last three months before study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified