Mass Balance Study of PM01183 (lurbinectedin) Administered as 1-hour Intravenous Infusion to Patients with Advanced Cancer

Completed

• Conditions: advanced cancer; solid tumors; 10027655

• Registration Number: NL-OMON45543
• Lead Sponsor: Pharma Mar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-09-04
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1) Voluntarily signed and dated written informed consent (IC) obtained from the patient prior to any specific study procedure.
2) Patient*s availability to stay in the research unit up to a minimum of eight days.
3) Patients with histologically/cytologically confirmed solid malignant disease (not recorded in the exclusion criteria), for which no standard therapy would reasonably be expected to result in cure or palliation.
4) Age >= 18 years.
5) Body Surface Area (BSA) >= 1.56 m2.
6) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 2.
7) Adequate organ function as reflected by:
a) Neutrophil count >= 1.5 x 10^9/L.
b) Platelet count >= 100 x 10^9/L.
c) Hemoglobin >= 9 g/dL (5.6 mmol/L).
d) Albumin >= 3.0 g/dL.
e) Calculated creatinine clearance (CrCL) >= 30 mL/min (using the Cockcroft and Gault*s formula).
f) Serum total bilirubin <= upper limit of normality (ULN) or, direct bilirubin < ULN if total bilirubin is > ULN and as long as total bilirubin <= 1.5 ULN.
g) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 3.0 x ULN.
h) Creatinine phosphokinase (CPK) <= 2.5 x ULN.
i) Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to
institutional standards).
8) Recovery to grade < 1 from any adverse event (AE) derived from previous treatment (alopecia of any grade and peripheral neuropathy [PN] grade < 2 are allowed).
9) Women of childbearing potential must have a negative serum pregnancy test before entering the study. Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for six months after treatment discontinuation. Highly effective methods of contraception include intrauterine contraceptive device (IUD), oral contraceptives, subdermal implant, bilateral tubal occlusion or vasectomy.
10) Patients must carry a central venous catheter.

Exclusion Criteria

1) Concomitant diseases/conditions:
a) History or presence of unstable angina, myocardial infarction, valvular heart
disease or congestive heart failure within the last 12 months.
b) Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment, and/or
prolonged QT-QTc grade >= 2.
c) Active uncontrolled infection.
d) Limitation of the patient*s ability to comply with the treatment or follow-up
protocol.
e) Any other major illness that, in the Investigator*s judgment, will substantially
increase the risk associated with the patient*s participation in this study. This
includes but is not limited to, any significant disease such as significant
cardiovascular, pulmonary, endocrine, renal, neurological or psychiatric
disorder.
2) Symptomatic, progressive or corticosteroid-requiring documented brain metastases
or leptomeningeal disease (controlled and stable or non-progressing brain
metastases without steroids are allowed).
3) Patients with the following tumors:
1) Concomitant diseases/conditions:
a) History or presence of unstable angina, myocardial infarction, valvular heart disease or congestive heart failure within the last 12 months.
b) Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment, and/or prolonged QT-QTc grade >= 2.
c) Active uncontrolled infection.
d) Limitation of the patient*s ability to comply with the treatment or follow-up protocol.
e) Any other major illness that, in the Investigator*s judgment, will substantially increase the risk associated with the patient*s participation in this study. This includes but is not limited to, any significant disease such as significant cardiovascular, pulmonary, endocrine, renal, neurological or psychiatric disorder.
2) Symptomatic, progressive or corticosteroid-requiring documented brain metastases or leptomeningeal disease (controlled and stable or non-progressing brain metastases without steroids are allowed).
3) Patients with the following tumors:
a) Colorectal cancer.
b) Primary CNS tumors.
4) Women who are pregnant or breast-feeding.
5) High transfusion requirements (> two packages or units of red blood cells and/or one platelet transfusion) within 30 days prior to inclusion in the study.
6) Chemotherapy, radiotherapy, immunotherapy or molecular targeted cancer therapy within four weeks prior to the start of PM01183 administration (six weeks for mitomycin C, nitrosourea therapy, temozolomide and other minor groove binders). This restriction does not apply to steroids and/or
bisphosphonates.
7) Major surgical procedure within the last eight weeks prior to the first PM01183 administration.
8) Wide-field radiotherapy (> 25% of bone marrow [BM] reserve) within 12 months prior to administration of PM01183 (pelvic radiation is considered 25% BM reserve).
9) Known hypersensitivity to any of the excipients used.
10) Participation in another clinical study or concomitant treatment with any investigational product in the 30-day period prior to inclusion in the study and/or participation in a 14C study within the last six months prior to screening for the current study. Total radioactivity exposure from the
current study and any previous 14C study must not exceed 5 mSv.
11) Tumoral or other conditions affecting the gastrointestinal (GI) tract or near the GI tract expected to induce total or partial occlusion of the GI transit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified