- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02664103
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer (METRO-ABC)
30 januari 2018 uppdaterad av: Sanofi
A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
Primary Objectives:
- To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer.
- To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer.
Secondary Objectives:
- To assess antitumor activity of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer given at 3 different doses and schedules (regimen 1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low dose [OD])
- Disease Control Rate (DCR)
- Overall Response Rate (ORR)
- Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).
- To evaluate the compliance under treatment.
- To describe evolution of toxicities.
- To assess safety all along patient's treatment.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Primary objective will be evaluated at 12 weeks.
Patients who show evidence of efficacy will be treated and followed-up until progression of the disease.
Studietyp
Interventionell
Inskrivning (Faktisk)
2
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Kollkata, Indien, 700053
- Investigational Site Number 356009
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Mumbai, Indien, 400012
- Investigational Site Number 356002
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New Delhi, Indien, 110085
- Investigational Site Number 356007
-
Trivandrum, Indien, 695011
- Investigational Site Number 356008
-
Vellore, Indien, 632004
- Investigational Site Number 356001
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion criteria:
- Female ≥18 and ≤65 years old.
- Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of the following characteristics:
- Recurrence of the disease following at least 2 lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following at least 1 line of chemotherapy failure and 2 lines of hormonal therapy failure.
- Patients who have been previously treated with capecitabine can be recruited in the study provided:
- As per the Investigator's opinion, patients will benefit from this chemotherapy AND
- For prior single administration of capecitabine: at least 6 months has elapsed between last capecitabine treatment and initiation of study treatment.
- For prior capecitabine-based combination regimen: at least 12 months has elapsed between last capecitabine-based treatment and initiation of study treatment.
- At least one unidimensionally measurable lesion according to RECIST criteria version 1.1.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
- Life expectancy of >3 months.
- Patients who are willing to undergo (oral) chemotherapy for the treatment of their disease and who are expected to comply with the treatment and study procedures, as per the Investigator's judgment.
- For women of child bearing potential, documented negative pregnancy test and agreement to use acceptable birth control measures during the duration of the study.
- Signed Informed consent obtained prior to any study related procedures.
Exclusion criteria:
- Patients who are HER 2 positive.
- Patients with 3 or more lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following 2 or more lines of chemotherapy failure and/or 3 or more lines of hormonal therapy failure.
- Patients presenting with de novo stage IV metastatic breast cancer, not previously treated for their disease.
- Patients who have already received any metronomic chemotherapy regimen.
- Known hypersensitivity to capecitabine or to any of its components.
- Known hypersensitivity to 5-fluorouracil.
- Known hypersensitivity to cyclophosphamide or any of its components.
- History of bladder carcinoma.
- Systemic anticancer therapy (chemotherapy, hormone therapy, or radiotherapy) within 4 weeks of randomization for the study.
- History of unexplained hematuria.
- History of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]).
- Concomitant warfarin treatment.
- History of significant cardiac disease (eg, unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) within the previous 6 months.
- Conditions/situations such as:
- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, Study coordinator, other staff, or relative thereof, directly involved in the conduct of the protocol.
- Uncooperative Patient or any condition that could make the Patient potentially noncompliant to the study procedures.
- Pregnant or breast-feeding women.
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- Patients with a possibility of active tuberculosis as suggested by:
- Any signs or symptoms suggestive of active tuberculosis upon medical history or clinical examination.
- Chest radiograph within 3 months prior to the screening visit consistent with tuberculosis infection.
- Patients with close contact with a person with active tuberculosis.
- Known history of Human Immunodeficiency Virus (HIV).
- Any other significant medical conditions which in the judgment of the Investigator would preclude completion of the study.
- Participation in a clinical research study evaluating another investigational drug or therapy within 30 days prior to the Screening Visit.
- Presence of any of the following laboratory abnormalities at the Screening Visit:
- Hemoglobin <8.5 g/L;
- White blood cell (WBC) <3000/μL;
- Platelet count <100 000/μL;
- Absolute neutrophil count (ANC) <1500/μL;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) (or > 5 x ULN in patients with liver metastasis);
- Total Bilirubin >1.5 X ULN (or > 2 x ULN in patients with liver metastasis).
- Patients with a body surface area (BSA) <1.0 m² or 1.8 m².
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: SAR439281(Cohort 1)
Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption
|
Pharmaceutical form:Tablet Route of administration: Oral
|
Experimentell: SAR439281(Cohort 2)
Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption
|
Pharmaceutical form:Tablet Route of administration: Oral
|
Experimentell: SAR439281(Cohort 3)
Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption
|
Pharmaceutical form:Tablet Route of administration: Oral
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Andel patienter med biverkningar
Tidsram: 12 veckor
|
12 veckor
|
Assessment of PK parameter: maximum concentration (Cmax)
Tidsram: Daily 12 weeks
|
Daily 12 weeks
|
Assessment of PK parameter: time to reach Cmax (Tmax)
Tidsram: Daily 12 weeks
|
Daily 12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Disease Control Rate (DCR)
Tidsram: 12 weeks
|
12 weeks
|
Objective Response Rate (ORR)
Tidsram: 12 weeks
|
12 weeks
|
Time to Progression (TTP)
Tidsram: 12 weeks
|
12 weeks
|
Proportion of patients compliant with treatment
Tidsram: 12 weeks
|
12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 januari 2016
Primärt slutförande (Faktisk)
6 november 2017
Avslutad studie (Faktisk)
6 november 2017
Studieregistreringsdatum
Först inskickad
15 januari 2016
Först inskickad som uppfyllde QC-kriterierna
21 januari 2016
Första postat (Uppskatta)
26 januari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 februari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Cyklofosfamid
- Capecitabin
Andra studie-ID-nummer
- CAPCYR07568
- U1111-1166-1149 (Annan identifierare: UTN)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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