Phase II study of PM60184 in patients with advanced colon-rectal cancer after standard treatment.
- Conditions
- Advanced Colorectal CancerMedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000257-39-ES
- Lead Sponsor
- Pharma Mar, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1) Voluntarily written informed consent, obtained before the
beginning of any study-specific procedures.
2) Age > or = 18 years.
3) Histologically-cytologically documented adenocarcinoma of
colon or rectum that has progressed to the last prior treatment
before inclusion.
4) Measurable disease according to Response Evaluation Criteria
in Solid Tumors (RECIST) v.1.1. If the only tumor lesion is situated in a previously irradiated area or in an area subjected
to other loco-regional therapy, progression in the lesion must
be demonstrated radiologically.
5) Previous treatment in any setting with fluoropyrimidine,
oxaliplatin and irinotecan in any combination (unless any is
contraindicated).
a) Adjuvant chemotherapy-based treatments count as prior
therapy, as long as relapse had occurred during or within
six months of completion of such therapies.
b) Cumulative dose of prior oxaliplatin (if any) must be
known.
c) Prior cetuximab, panitumumab, bevacizumab, aflibercept,
and regorafenib are allowed.
6) No more than two prior therapies for metastatic disease.
7) Washout periods for prior therapies (defined in relation to
planned start of study treatment [first dose administration]):
a) At least three weeks since the last administration of an
antineoplastic treatment (chemotherapy, biological,
targeted or investigational therapies).
b) At least three weeks since radiotherapy involving up to
35% of bone marrow (radiotherapy involving > 35% of
bone marrow is not allowed) or two weeks since the end
of palliative radiotherapy including single doses.
c) At least four weeks since any major surgical procedure,
open biopsy, or significant traumatic injury.
8) Eastern Cooperative Oncology Group (ECOG) performance
status (PS) 0 or 1.
9) Life expectancy > or = 3 months.
10)Adequate bone marrow, liver, and kidney function:
a) Hemoglobin > or = 9 g/dL.
b) Absolute neutrophil count > or =1.5 × 10 9/L.
c) Platelet count > or = 100 × 10 9/L.
d) Serum creatinine < or = 1.5 mg/dL or calculated creatinine
clearance > or = 40 mL/min (Cockcroft-Gault formula).
e) Albumin > or = 2.5 g/dL.
f) Total serum bilirubin < or = 1.5 times the upper limit of normal
(ULN), except in case of Gilbert syndrome.
g) Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) < or = 3 × ULN (< or = 5.0 × ULN in the
case of liver metastases).
11)Recovery to grade < or = 1 from any toxicity due to previous
therapy (including peripheral sensory/motor neuropathy but
excluding alopecia).
12)Left ventricular ejection fraction (LVEF) by echocardiography
(ECHO) or multiple-gated acquisition (MUGA) scan within
normal range (according to institutional sta
1) Prior exposure to PM060184.
2) Known hypersensitivity to the study drug class or study drug
excipient in the formulation.
3) Patients with locally advanced disease amenable to local
and/or curative therapy (surgery or radiotherapy) at study
entry.
4) Other serious and/or relevant diseases or clinical situations
that, in the opinion of the Investigator, are incompatible with
the protocol (including any of the following):
a) History of another neoplastic disease (except for basal cell
carcinoma of the skin, superficial bladder tumors, or
properly treated carcinoma in situ of the uterine cervix or
melanoma in situ) unless in remission for at least five
years and with no recurrence.
b) Symptomatic cerebral and/or leptomeningeal metastasis,
spinal cord compression or carcinomatous meningitis.
c) Neuropathy of any etiology (other than that caused by
previous antineoplastic therapy).
d) History of cardiac disease, such as myocardial infarction,
in the year prior to registration in the clinical trial;
symptomatic/uncontrolled angina pectoris; congestive
heart failure or uncontrolled cardiac ischemia; any type of
uncontrolled arrhythmia, congenital and/or prolonged QT
interval or abnormal LVEF, or uncontrolled arterial
hypertension (according to the standards of the World
Health Organization [WHO]).
e) History of significant psychiatric disease.
f) Active infection requiring antibiotic, antifungal or
antiviral treatment that, in the opinion of the Investigator,
could compromise the patient’s capacity to tolerate the
therapy.
g) Known active liver (hepatitis B or C or cirrhosis) or renal
disease.
h) Known human immunodeficiency virus (HIV) infection.
i) Any other concomitant pathology that could jeopardize
the patient’s safety or commitment to complete the
clinical trial.
j) Inability or refusal to comply with the protocol or with the
clinical trial procedures.
5) Pregnancy or lactation.
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