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Trial · Interventional

CompletedPhase 2Registry data

Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

Overview

Status
Completed
Phase
Phase 2
Enrollment
21 participants (actual)
Sponsor
Laboratorio Elea Phoenix S.A. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Argentina

Start
Nov 2011
Primary completion
Feb 2015
Completion
Jul 2015
First posted
25 May 2012 (estimated)
Last update posted
28 Aug 2015 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph 2

    Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

    NCT01606072

    Nov 2011 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.

Interventions

  • DesmopressinDrug

Arms1

  • Experimental

    Desmopressin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Selection of the higher safe dose level for ensuing clinical trials

    Time frame · Up to 2 years

    Registry description

    One of the three dose levels assessed in this study will be selected for further clinical testing in adults: 0,50 mg, 1,0 mg, 1,25 mg, 1,5 mg or 2,0 mg.

Secondary outcomes(16)
  1. Evidence of V2 Receptor Expression

    Time frame · Baseline

  2. Evidence of CTC (CIRCULATING TUMOR CELLS)

    Time frame · Baseline

  3. Evidence of Von Willebrand factor antigen (VWF:Ag)

    Time frame · Baseline

  4. Evidence of CTC (circulating tumor cells)

    Time frame · 30 minutes pre surgery and 24 hours post the surgery

  5. Evidence of CTC (circulating tumor cells)

    Time frame · 2 Weeks

  6. Evidence of CTC (circulating tumor cells)

    Time frame · 1 Month

  7. Evidence of CTC (circulating tumor cells)

    Time frame · 3 Months

  8. Evidence of CTC (circulating tumor cells)

    Time frame · 6 Months

  9. Evidence of CTC (circulating tumor cells)

    Time frame · 12 Months

  10. Evidence of Von Willebrand factor antigen (VWF:Ag)

    Time frame · 120 minutes post the surgery

  11. Evidence of VWF activity (ristocetin cofactor, VWF:RCo)

    Time frame · baseline

  12. Evidence of VWF activity (ristocetin cofactor, VWF:RCo)

    Time frame · 120 minutes post the surgery

  13. Evidence of FVIII coagulant activity (FVIII:C)

    Time frame · baseline

  14. Evidence of FVIII coagulant activity (FVIII:C)

    Time frame · 120 minutes post the surgery

  15. Evidence of euglobulin lysis time

    Time frame · baseline

  16. Evidence of euglobulin lysis time

    Time frame · 120 minutes post the surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2015

7 results

A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients.

Weinberg et al. 2015SpringerPluscited by 32

PMID 26306290PMC4540720DOI 10.1186/s40064-015-1217-yPUB-26306290

CC BY7 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * a. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form. b. Histological/cytological diagnosis of breast carcinoma obtained at least 21 days before inclusion into the study. c. Candidate for radical mastectomy and requiring resection of axillary lymph nodes or sentinel node. d. In case of women of childbearing potential, an adequate birth control method (intrauterine device, barrier methods, or tubal ligation) should be used throughout the study. Post-menopausal women should have menopause confirmed by biochemical parameters. e. Adequate organic function, defined by the following parameters: * Electrocardiogram (ECG) with no significant anomalies, performed within 14 days prior to surgery. * The following laboratory results, obtained 7 days before surgery: * Hemoglobin ≥ 11 g/dL * Total white blood cell count ≥ 4,000/mm3 * Total neutrophil count 1,500/mm3 * Platelet count within normal limits * Total bilirubin ≤1.5 x UNL or 2.5 x UNL in case of hepatic metastasis * Transaminases ALT/GPT and AST/GOT ≤ 1.5 x UNL * Creatinine clearance \>50 mg/dL * CT scan with oral and endovenous contrast\* of chest, pelvis, and abdomen, and bone scan, conducted within 28 days prior to surgery. Images taken not longer than 90 days before surgery are also acceptable. * In case contrast is contraindicated, CT with no contrast or MRI will be performed. f. Subject with performance status (ECOG) = 0. Exclusion Criteria: * a. Synchronic bilateral breast cancer. b. Symptoms of metastasis or evidence of metastasis from images: chest spiral CT scan, abdomen/pelvis spiral CT scan, brain spiral CT/MRI (in case of brain metastasis signs), and bone scan. c. The patient is pregnant or breastfeeding. d. The patient is presently using hormonal contraceptives or under hormonal treatment. She would be eligible if oral contraceptives were discontinued or if the hormonal treatment finished 30 days before surgery and the patient agreed to use another contraceptive method. e. Patients with a history or presence of congestive heart failure, blood hypertension, angina pectoris or heart arrhythmia, thromboembolic disease, diabetes type I or II, or any underlying coronaropathy detected in pre-surgical evaluations. f. Mentally-impaired patients. g. Patients with known hypersensitivity to DDAVP or vasopressin, o with severe von Willebrand's disease (VWD), defined by a VWF activity \<10%IU/dL, or type 2B VWD, defined by an increased ristocetin-induced platelet aggregation (RIPA) at low concentrations of ristocetin or with hemophilia. h. Patients with a history of seizures. i. Patients with renal impairment (creatinine clearance \< 50 mL/min calculated by the Cockcroft-Gault formula), hyponatremia or with a history of hyponatremia. j. Patients with syndrome of inadequate secretion of antidiuretic hormone. k. Patients with positive serology for the hepatitis B or C virus and/or HIV. l. Patients with known hepatic disease (diagnosed cirrhosis, hepatic enzymes (GOT/GPT) \> 1.5 x UNL, Total bilirubin \> 1.5 x UNL). m. Patients with active infections. n. Patients with other malignant diseases, with the exception of, non-melanoma skin cancer, or cervix cancer in situ, or any other tumor that has received adequate treatment and shows a disease-free time ≥ 5 years. o. Patients participating in another clinical study or cases in which less than 4 weeks have elapsed since participation in another clinical study.

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