AzTrials
AzTrials

Ovarian CancerPhase 2MITO-11NCT01644825

Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer

A Phase 2 study testing paclitaxel and pazopanib in people with Ovarian Cancer, run by National Cancer Institute, Naples at 20 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
paclitaxel and pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
20 sitesItaly
Study dates
Dec 2010to 29 Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
  • Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment
  • Disease evaluable by RECIST or Ca 125 GCIG criteria
  • No residual peripheral neurotoxicity from previous chemotherapy treatment
  • PS 0-1
  • Aged at least 18 and not greater than 75 years.
Show all 10Show fewer
  • Life expectancy of at least 3 months
  • Able to swallow and retain oral medication
  • Written informed consent prior to performance of study specific procedures or assessments
  • Ability and willingness to comply with treatment and follow up assessments and procedures

Who cannot join

  • • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Previous treatment with weekly paclitaxel
  • More than 2 previous chemotherapy treatments
  • Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
  • Hemoglobin < 9 g/dL, neutrophils < 1500/mm3, platelets < 100000/mm3
  • Impairment of renal function (patients should have 2 functioning kidneys): creatinine 1.5 times the upper normal limit - UNL; calculated creatinine clearance < 50 mL/min; urine protein to creatinine ratio > or = 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value <1gr to be eligible
Show all 20Show fewer
  • Impairment of liver function (SGOT or SGPT > or = 2.5 UNL, alkaline phosphatase > 2.5 ULN, total bilirubin > 1.5 times the UNL)
  • Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) > 1.2 times the UNL
  • Pregnancy, breast feeding, or inadequate contraception
  • Unable to discontinue prohibited medications (see protocol section 6.7)
  • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment, signs or symptoms of GI obstruction
  • Any unstable or serious concurrent condition
  • Prolongation of corrected QT interval (QTc) >480 ms
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Macroscopic hematuria
  • Major surgery or trauma within 30 days
  • Hypertension uncontrolled with adequate therapy (systolic blood pressure (BP) of > or = 140mmHg, or diastolic BP of > or = 90mmHg)
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity
  • Present or suspected haemorrhagic syndromes
  • Patients' inability to access the centre due to area of residence

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Italy20 sites

  • Osp. Regionale Mulli

    Acquaviva delle Fonti

  • Ospedale San donato

    Arezzo

  • A.O. G. Rummo

    Benevento

  • Ospedale Bellaria

    Bologna

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • A.O. Garibaldi Nesimadi Catania

    Catania

  • Ospedale Civile di Faenza

    Faenza

  • A.O.U. Arcispedale Sant'Anna di Ferrara

    Ferrara

  • Ospedale Fabrizio Spaziani della ASL di Frosinone

    Frosinone

  • Ospedale Umbero I

    Lugo

  • Istituto Nazionale Tumori

    Milan

  • A.O. Univeristaria Policlinico

    Modena

  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

    Naples, 80131

  • Seconda Universita di Napoli

    Naples

  • Ospedale Silvestrini

    Perugia

  • Ospedale S. Maria delle Croci AUSL di Ravenna

    Ravenna

  • A.O. Bainchi Melacrino Morelli Osp. Riuniti

    Reggio Calabria

  • Ospedale degli Infermi, P.O. Ospedale Civile

    Rimini

  • Policlinico Umberto I

    Roma

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma

Other trials in Italy

About this study

Official title: MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer

The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.

Conditions
Ovarian Cancer
Being tested
paclitaxel, pazopanib
Keywords
platinum resistant, platinum refractory
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paclitaxelDrug

    80 mg/m2 IV days 1, 8, 15 every 28 days

  • pazopanibDrug

    orally, 800 mg orally daily

Study groups in NCT01644825
Study groupRoleWhat they receive
paclitaxel and pazopanibExperimentalNot described
Receives: Drug: paclitaxel; Drug: pazopanib
paclitaxelActive comparatorNot described
Receives: Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: 6 months from randomization

Secondary outcomes (3)

  1. number of patients with objective response

    Measured: at 2 months and 4 months after randomization

  2. worst grade toxicity per patient

    Measured: at end of each 28 day cycle of therapy

  3. overall survival

    Measured: one year from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2014
  4. Study completion29 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644825
Sponsor's protocol ID
MITO-11
Other IDs
2009-016151-21, 2009
Acronym
MITO-11
Status last verified
Apr 2018
First submitted
17 Jul 2012
Last updated
9 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • Pignata S, Lorusso D, Scambia G, Sambataro D, Tamberi S, Cinieri S, Mosconi AM, Orditura M, Brandes AA, Arcangeli V, Panici PB, Pisano C, Cecere SC, Di Napoli M, Raspagliesi F, Maltese G, Salutari V, Ricci C, Daniele G, Piccirillo MC, Di Maio M, Gallo C, Perrone F; MITO 11 investigators. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial. Lancet Oncol. 2015 May;16(5):561-8. doi: 10.1016/S1470-2045(15)70115-4. Epub 2015 Apr 14.

    PubMed 25882986

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel and pazopanib in people with Ovarian Cancer, run by National Cancer Institute, Naples at 20 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: 6 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644825, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in