Clinical trial • Phase II • Oncology

Trifluridine; Tipiracil hydrochloride for Metastatic colorectal cancer

Phase II trial of Trifluridine; Tipiracil hydrochloride for Metastatic colorectal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic colorectal cancer
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
11-09-2024
First CTIS Authorization Date
16-10-2024

Trial design

Randomised, open-label, arm a: trifluridine/tipiracil 35 mg/m² bsa, bid, orally on days 1–5 and 8–12 plus panitumumab 6 mg/kg body weight iv infusion on days 1 and 15. arm b: trifluridine/tipiracil 35 mg/m² bsa, bid, orally on days 1–5 and 8–12 plus bevacizumab 5 mg/kg body weight iv infusion on days 1 and 15.-controlled Phase II trial in Germany.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Trifluridine/tipiracil 35 mg/m² BSA, BID, orally on Days 1–5 and 8–12 plus Panitumumab 6 mg/kg body weight IV infusion on Days 1 and 15. Arm B: Trifluridine/tipiracil 35 mg/m² BSA, BID, orally on Days 1–5 and 8–12 plus Bevacizumab 5 mg/kg body weight IV infusion on Days 1 and 15.
Target Sample Size
153

Eligibility

Recruits 153 Only adults (Patients ≥ 18 years). 'Patient’s signed informed consent' is required. The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). The exclusion criteria explicitly exclude persons with 'Limited legal capacity', 'Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities', and 'Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator'..

Pregnancy Exclusion
Pregnant or breastfeeding females
Vulnerable Population
Only adults (Patients ≥ 18 years). 'Patient’s signed informed consent' is required. The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). The exclusion criteria explicitly exclude persons with 'Limited legal capacity', 'Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities', and 'Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator'.

Inclusion criteria

  • {"criterion_text":"- Patient’s signed informed consent"}
  • {"criterion_text":"- Patients without anticoagulation need to present with an INR <1.5 x ULN and PTT <1.5 x ULN. Patients with anticoagulation may be enrolled if the patient receives the medication at a stable dose for at least 2 weeks before randomisation and provided that INR and PTT are <1.5 x ULN."}
  • {"criterion_text":"- For females of childbearing potential (FCBP): negative pregnancy test within 14 days before randomisation and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male partner’s sterilization, hormonal contraceptives that inhibit ovulation supplemented with a barrier method, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception."}
  • {"criterion_text":"- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for 6 months after the last dose of study treatment. In this regard, double barrier methods are not considered to have a failure rate of < 1%. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception."}
  • {"criterion_text":"- Patients ≥ 18 years at the time of signing the informed consent"}
  • {"criterion_text":"- Histologically confirmed adenocarcinoma of the colon or rectum (appendix carcinoma is excluded)"}
  • {"criterion_text":"- Metastatic colorectal cancer (mCRC) with at least one measurable lesion according to RECIST 1.1 in a computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within 5 weeks prior to randomisation"}
  • {"criterion_text":"- Metastases are primarily unresectable or patient is unable/unwilling to undergo surgery"}
  • {"criterion_text":"- RAS wild-type (KRAS, exons 2, 3, 4 and NRAS, exons 2, 3, 4) mCRC, proven in the primary tumor or metastasis. The RAS mutational status must be determined by means of a validated test method."}
  • {"criterion_text":"- Patient is not eligible to undergo combination chemotherapy according to investigator’s assessment or unwilling to undergo combination chemotherapy."}
  • {"criterion_text":"- ECOG performance status 0-2"}
  • {"criterion_text":"- Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results: • Absolute neutrophil count ≥1.5 x 109/L (1500/µL) • Hemoglobin ≥ 80 g/L (8 g/dL) • Platelet count ≥ 75 x109/L (75,000/µL) without transfusion • Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN) • Aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT) ≤ 2.5 × ULN; if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN • Calculated glomerular filtration rate (GFR) according to Cockcroft –Gault formula or according to MDRD ≥ 30 mL/min or serum creatinine ≤ 1.5 x ULN •\tUrine dipstick for proteinuria < 2+ (within 14 days prior to randomisation), unless a subsequent 24-hour urine collection demonstrates < 1 g of protein in 24 hours."}

Exclusion criteria

  • {"criterion_text":"- Prior systemic therapy of metastatic disease. Note: Prior adjuvant chemotherapy is permitted, if completed > 3 months prior to randomisation. Multimodal treatment of rectal cancer is not considered anti-metastatic therapy and does not preclude study participation"}
  • {"criterion_text":"- History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess -unrelated to surgery- within 6 months prior to randomisation."}
  • {"criterion_text":"- Acute or subacute bowel obstruction, active chronic inflammatory bowel disease or chronic diarrhea"}
  • {"criterion_text":"- History of keratitis, ulcerative keratitis or severe dry eye."}
  • {"criterion_text":"- Hypersensitivity to trifluridine/tipiracil or panitumumab or bevacizumab or any of the excipients, known hypersensitivity to Chinese hamster ovary cell products, known hypersensitivity to human or humanized antibodies"}
  • {"criterion_text":"- Current or recent (within 10 days of randomisation) use of or anticipated need for continuous treatment during study treatment with acetylsalicylic acid > 325 mg/day or treatment with dipyramidole, ticlopidine > 2 x 250 mg/day, clopidogrel > 75 mg/day, and cilostazol. Combination of these drugs are not allowed."}
  • {"criterion_text":"- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 28 days prior to randomisation or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure"}
  • {"criterion_text":"- Core biopsy or other minor surgical procedure, excluding placement of a vascular access devices, within 3 days prior to the first dose of bevacizumab"}
  • {"criterion_text":"- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis/interstitial pneumonia, or idiopathic pneumonitis/interstitial pneumonia, or evidence of active pneumonitis or pulmonary fibrosis on screening chest imaging"}
  • {"criterion_text":"- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications."}
  • {"criterion_text":"- Medical history of other malignant disease than mCRC with the following exceptions: - patients who have been disease-free for at least three years before randomisation - patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer – patients with any treated or untreated malignant disease that is associated with a 5 year survival prognosis of ≥90% and does not require active therapy"}
  • {"criterion_text":"- Known brain metastasis. In case of symptoms that are suggestive of brain metastasis, brain metastasis has to be ruled out by means of cranial CT/MRI."}
  • {"criterion_text":"- Known alcohol or drug abuse"}
  • {"criterion_text":"- Pregnant or breastfeeding females"}
  • {"criterion_text":"- Participation in a clinical trial or experimental drug treatment within 28 days prior to inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial."}
  • {"criterion_text":"- Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities"}
  • {"criterion_text":"- Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator"}
  • {"criterion_text":"- Limited legal capacity"}
  • {"criterion_text":"- Significant cardiovascular disease such as: New York Heart Association Class III or greater heart failure; myocardial infarction within 6 months prior to randomisation; balloon angioplasty (PTCA) with or without stenting within 6 months prior to randomisation; despite anti-arrhythmic therapy unstable cardiac arrhythmia > grade 2 NCI CTCAE; unstable angina pectoris"}
  • {"criterion_text":"- Transient ischaemic attack or cerebrovascular accident within 6 months prior to randomization, history of cerebral or aortic aneurysm or dissection"}
  • {"criterion_text":"- Medical history of deep vein thrombosis or pulmonary embolism within 6 months prior to randomisation or medical history of recurrent thromboembolic events (> 1 episode of deep vein thrombosis, pulmonary embolism, peripheral embolism) within the last 2 years."}
  • {"criterion_text":"- Severe bleeding event within the last 6 months before randomisation (except tumor bleeding surgically treated by tumor resection)"}
  • {"criterion_text":"- Evidence of bleeding diathesis or significant coagulopathy"}
  • {"criterion_text":"- Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and/or diastolic ≥ 100 mm Hg under antihypertensive medication"}
  • {"criterion_text":"- Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective response rate (ORR) according to RECIST 1.1 (assessment at the local trial center)","definition_or_measurement_approach":"Assessment according to RECIST 1.1, performed at the local trial center."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Objective response rate (ORR) according to RECIST 1.1 (assessment by central review)","definition_or_measurement_approach":"Assessment according to RECIST 1.1 by central review."}
  • {"endpoint_text":"- Depth of response (DpR) (assessment by central review)","definition_or_measurement_approach":"Assessment by central review."}
  • {"endpoint_text":"- Early tumor shrinkage ([ETS]; assessment by central review)","definition_or_measurement_approach":"Assessment by central review."}
  • {"endpoint_text":"- QoL as assessed with the QoL questionnaire EQ-5D-5L","definition_or_measurement_approach":"Patient-reported quality of life measured using EQ-5D-5L questionnaire."}
  • {"endpoint_text":"- Type, incidence, severity, and causal relationship to IMPs of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0)","definition_or_measurement_approach":"Safety measured by type, incidence, severity and causal relationship; severity graded per CTCAE v5.0."}
  • {"endpoint_text":"- Subsequent anti-tumor treatment lines (monotherapy and combination therapy treatment lines including medicinal products [chemotherapeutics, antibodies and targeted therapy] and investigator reported efficacy of subsequent treatment lines","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Identification of biomarker for treatment efficacy and toxicity","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
153
Recruitment Window Months
108
Consent Approach
Signed informed consent required from each participant ('Patient’s signed informed consent'). Subject information and informed consent form documents for adults are present (multiple L1_SIS and ICF adults documents). Only adults (≥18 years) are eligible; no pediatric/assent documents were provided in the available materials. Languages of consent documents are not specified in the provided data.

Geography

Total Number Of Sites
42
Total Number Of Participants
153

Germany

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
555
Number Of Sites
42
Number Of Participants
153

Sites

Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Med. Klinik V, Klinik f. Hämatologie u. Onkologie mit Palliativmedizin
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
anke.reinacher@rub.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Kliniken für internistische Hämatologie und Onkologie mit integrierter Palliativmedizin
Contact Person Name
Christian Müller
Contact Person Email
ch.mueller@kem-med.com
Site Name
Universitätsklinikum Düsseldorf
Department Name
Klinik für Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Christoph Roderburg
Site Name
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel
Department Name
Klinik für Innere Medizin II m. S. Hämatologie und Onkologie
Contact Person Name
Anne Letsch
Contact Person Email
Anne.Letsch@uksh.de
Site Name
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Department Name
Hämatologie/Onkologie
Contact Person Name
Tobias Dechow
Contact Person Email
dechow@onkonet.eu
Site Name
Johannes Wesling Klinikum Minden
Department Name
Universitätsklinik für Hämatologie, Onkologie, Gerinnungsstörungen und Palliativmedizin
Contact Person Name
Hans-Joachim Tischler
Site Name
Sozialstiftung Bamberg Klinik am Bruderwald
Department Name
Studienzentrale
Contact Person Name
Christof Schweizer
Site Name
Klinikum Magdeburg gGmbH
Department Name
Klinik für Hämatologie,Onkologie u. Palliativmedizin
Contact Person Name
Christian Plate
Site Name
München Klinik Neuperlach
Department Name
Klinik f. Hämatologie und Onkologie
Contact Person Name
Michael Haas
Site Name
Brüderkrankenhaus St. Josef Paderborn
Department Name
Klinik f. Hämatologie u. Onkologie
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik m. S. Hämatologie und Onkologie und Tumorimmunologie am Campus Virchow Klinik
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Praxis am Volkspark
Department Name
Onkologische Schwerpunktpraxis
Contact Person Name
Jan-Piet Habbel
Site Name
Augusta-Kranken-Anstalt gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativ
Contact Person Name
Dirk Behringer
Contact Person Email
behringer@augusta-bochum.de
Site Name
Medicum Rosenheim MVZ GmbH
Department Name
Innere Medizin – Onkologie – Gastroenterologie – Diabetologie
Contact Person Name
Rudolf Pihusch
Contact Person Email
rudolf.pihusch@pihusch.de
Site Name
Klinikum St Marien Amberg
Department Name
Studienzentrum
Contact Person Name
Ludwig Fischer von Weikersthal
Site Name
Studienzentrum Onkologie Unter Ems
Department Name
Hämatologie / Onkologie
Contact Person Name
Lothar Müller
Contact Person Email
lothar.mueller@onkologie-ue.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m. S. Hämatologie/Onkologie Charité Comprehensive Cancer Center
Contact Person Name
Annabel Alig
Contact Person Email
annabel.alig@charite.de
Site Name
Onkologische Praxis
Department Name
Hämatologie/Onkologie
Contact Person Name
Tobias Dechow
Contact Person Email
dechow@onkonet.eu
Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik f. Innere Med. I
Contact Person Name
Gerhard Behre
Site Name
Klinikum München-Bogenhausen
Department Name
Onkol. Tagesklinik
Contact Person Name
Martin Fuchs
Site Name
Onkologische Schwerpunktpraxis (OSP) Kurfürstendamm
Department Name
Hämatologie / Onkologie
Contact Person Name
Ingo Schwaner
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik f. Onkologie u. Hämatologie
Contact Person Name
Börge Arndt
Site Name
LMU Ludwig-Maximilians-Universität München
Department Name
Med. Klinik III
Contact Person Name
Volker Heinemann
Site Name
ÜBAG MVZ Dr. Vehling-Kaiser GmbH
Department Name
ÜBAG
Contact Person Name
Florian Kaiser
Contact Person Email
dr.f.kaiser@vehling-kaiser.de
Site Name
Klinikum rechts der Isar
Department Name
Klinik u. Poliklinik für Innere Medizin III, Zentrum für klinische Studien
Contact Person Name
Sylvie Lorenzen
Contact Person Email
sylvie.lorenzen@mri.tum.de
Site Name
RoMed Klinikum Rosenheim
Department Name
Med. Klinik II
Contact Person Name
Gerhard Puchtler
Contact Person Email
gerhard.puchtler@ro-med.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik f. Innere Medizin I
Contact Person Name
Thomas Ettrich
Site Name
Klinik Esslingen GmbH, Klinik für Innere Medizin, Hämatologie ,Onkologie u. Gastroenterologie
Department Name
Hämatologie/Onkologie
Contact Person Name
Guido Hausner
Site Name
"Kliniken d. Stadt Köln gGmbH "
Department Name
Onkologische Ambulanz Holweide
Contact Person Name
Bernhard Sibbing
Contact Person Email
sibbingb@kliniken-koeln.de
Site Name
Universitätsmedizin Göttingen
Department Name
Klinik f. Gastroenterol u. gastrointestinale Onkologie & Klinik f. Allg.-, Viszeral- u. Kinderchir.
Contact Person Name
Ute König
Site Name
Fürst-Stirum-Klinik Bruchsal
Department Name
Klinik f. Gastroenterologie, Hämato-Onkologie, Pneumonologie, Infektiologie und Intensivmedizin
Contact Person Name
Holger Noga
Contact Person Email
holger.noga@rkh-gesundheit.de
Site Name
Alexianer Krefeld GmbH, Krankenhaus Maria Hilf, Klinik für Onkologie u. Gastroenterologie
Department Name
Onkologie/Gastroenterologie
Contact Person Name
Stefan Pluntke
Contact Person Email
s.pluntke@alexianer.de
Site Name
Charité - Universitätsmedizin Berlin CCM
Department Name
Med. Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
UNIVERSITÄTSKLINIKUM FREIBURG
Department Name
Klinik für Innere Medizin II
Contact Person Name
Michael Quante
Site Name
Hämato-Onkologische Studienkreis am Klinikum Aschaffenburg
Department Name
Praxis
Contact Person Name
Manfred Welslau
Site Name
Onkologische Schwerpunktpraxis im Medicinum Dr. med. Freier/ Dr. med. Sammler
Department Name
Onkologische Schwerpunktpraxis
Contact Person Name
Werner Freier
Contact Person Email
info@onkologie-hildesheim.de
Site Name
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Department Name
Med. Klinik II
Contact Person Name
Stephan Kanzler
Contact Person Email
skanzler@leopoldina.de
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Med. Klinik
Contact Person Name
Frank Jordan
Contact Person Email
frank.jordan@uk-augsburg.de
Site Name
Klinikum Bayreuth GmbH
Department Name
Med. Klinik IV - Innere Medizin
Contact Person Name
Alexander Kiani
Site Name
Dr. Vehling-Kaiser MVZ GmbH
Department Name
ÜBAG
Contact Person Name
Florian Kaiser
Contact Person Email
dr.f.kaiser@vehling-kaiser.de
Site Name
MVZ Onkologie im Klinikum Bayreuth GmbH
Department Name
MVZ Onkologie
Contact Person Name
Alexander Kiani

Sponsor

Primary sponsor

Full Name
Charite Universitaetsmedizin Berlin KöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"3,7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"10","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"1,12,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Trifluridine/Tipiracil (Lonsurf)
Active Substance
Trifluridine; Tipiracil hydrochloride
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorisation present (EU MA numbers listed)
Starting Dose
35 mg/m² BSA, BID orally on Days 1–5 and 8–12
Dose Levels
35 mg/m² (per protocol dosing); tablets available as 15 mg/20 mg strengths
Frequency
BID on specified dosing days (Days 1–5 and 8–12 of 28-day cycle)
Maximum Dose
maxDailyDoseAmount 70 mg/m2 (as listed), maxTotalDoseAmount 4200 (units per product record)
Investigational Product Name
Panitumumab (Vectibix)
Active Substance
Panitumumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present
Starting Dose
6 mg/kg body weight IV infusion on Days 1 and 15
Dose Levels
6 mg/kg (per protocol)
Frequency
Day 1 and Day 15 of each 28-day cycle
Maximum Dose
maxDailyDoseAmount 6 mg/kg, maxTotalDoseAmount 72 (per product record)
Investigational Product Name
Bevacizumab
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation code SUB16402MIG referenced)
Starting Dose
5 mg/kg body weight IV infusion on Days 1 and 15
Dose Levels
5 mg/kg (per protocol)
Frequency
Day 1 and Day 15 of each 28-day cycle
Maximum Dose
maxDailyDoseAmount 5 mg/kg, maxTotalDoseAmount 60 (per product record)
Combination Treatment
Yes

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