Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300987
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progression

Condition or disease Intervention/treatment Phase
Teratoma Drug: LEE011 Drug: LEE011 Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
Actual Study Start Date : February 26, 2015
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : February 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ribociclib

Arm Intervention/treatment
Active Comparator: LEE011 Drug: LEE011
Placebo Comparator: Placebo Arm Drug: LEE011 Placebo



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: at 4 months ]
    Date of randomization to the date of the first documented progression or death due to any causeas per RECIST v1.1 (by local investigator assessment).


Secondary Outcome Measures :
  1. Best Overall Response (BOR) [ Time Frame: at 4 months ]
    as per RECIST v1.1,

  2. Overall response rate (ORR) [ Time Frame: at 4 months ]
    as per RECIST v1.1,

  3. Disease Control Rate (DCR) [ Time Frame: At 4 months ]
    as per RECIST v1.1

  4. Overall Survival (OS) [ Time Frame: At 12 months ]
  5. Overal Survival rate [ Time Frame: at 12 months ]
  6. Incidence of adverse events (AEs) [ Time Frame: 48 months ]
    Changes in lab values, electrocardiograms (ECGs), and vital signs will be used to assess the safety as per common terminology criteria for adverse events (CTCAE) v.4.03. Dose interruptions and changes will be used to assess the tolerability.

  7. Incidence of serious adverse events (SAEs) [ Time Frame: 48 months ]
    Changes in lab values, electrocardiograms (ECGs), and vital signs will be used to assess the safety as per common terminology criteria for adverse events (CTCAE) v.4.03. Dose interruptions and changes will be used to assess the tolerability.

  8. Severity of adverse events (AEs) [ Time Frame: 48 months ]
    Changes in lab values, electrocardiograms (ECGs), and vital signs will be used to assess the safety as per common terminology criteria for adverse events (CTCAE) v.4.03. Dose interruptions and changes will be used to assess the tolerability.

  9. Severity of serious adverse events (SAEs) [ Time Frame: 48 months ]
    Changes in lab values, electrocardiograms (ECGs), and vital signs will be used to assess the safety as per common terminology criteria for adverse events (CTCAE) v.4.03. Dose interruptions and changes will be used to assess the tolerability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
  • Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor (except patients who present with primary pure teratoma who need not have received any previous chemotherapy)
  • Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks prior to enrollment, compared with scans within 1 year of enrollment.
  • Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
  • Meaurable or evaluable extra-cranial disease as defined by RECIST v 1.1

Exclusion Criteria:

  • Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma. Note - this refers to the histology at the time of enrollment, not the histolgy at the time of initial presentation.
  • Pathologic evidence of malignant transformation
  • CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation demonstrates stable disease
  • Prior treatment with any CDK4/6 inhibitor therapy
  • Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
  • Major surgery ≤ 2 weeks or radiotherapy ≤ 4 weeks prior to planned start of study drug or patient has not recovered from major side effects.
  • Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300987


Locations
Layout table for location information
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90033
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic - Rochester Onc Department
Rochester, Minnesota, United States, 55905
United States, New Mexico
Novartis Investigative Site
Albuquerque, New Mexico, United States, 87106
United States, New York
Novartis Investigative Site
New York, New York, United States, 10017
France
Novartis Investigative Site
Villejuif Cedex, France, 94805
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Netherlands
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Spain
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site
Madrid, Spain, 28041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02300987     History of Changes
Other Study ID Numbers: CLEE011X2201
2014-000428-12 ( EudraCT Number )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Teratoma,
Germ Cell tumor,
incurable teratoma,
CDK4/6,
LEE011
Additional relevant MeSH terms:
Layout table for MeSH terms
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms