Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. (PalboSarc)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242382
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Investigacion en Sarcomas

Brief Summary:

Non-randomized, open, single cohort, phase II, multicenter national clinical trial. 19 sites in Spain.

Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days.

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision

The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1 at 6 months


Condition or disease Intervention/treatment Phase
Sarcoma Advanced Cancer Drug: Palbociclib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Palbocilib
Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days.
Drug: Palbociclib
Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision
Other Name: Ibrance




Primary Outcome Measures :
  1. Progression free survival (PFS) rate [ Time Frame: At 6 months ]
    Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 6 months ]
    Efficacy measured through the objective response rate (ORR) (complete response [CR] and partial response [PR]), evaluated with RECIST 1.1 criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.

  2. Efficacy measures through response according to Choi criteria measured through response according to Choi criteria: [ Time Frame: 6 months ]
    Efficacy measures through response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.

  3. Efficacy measured through median PFS. [ Time Frame: 6 months ]
    Efficacy measured through median PFS. measured through median PFS:

  4. Efficacy measured through PFS rate at 3 months. [ Time Frame: 3 months ]
    Efficacy measured through PFS rate at 3 months.

  5. Overall survival (OS) [ Time Frame: 2 years ]
    Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.

  6. Clinical Benefit Rate (CBR) [ Time Frame: 6 months ]
    Clinical Benefit Rate (CBR). Patients having shown complete response, partial response, or disease stabilization during 6 months or more, showing clinical improvement symptoms, will be considered as having experienced clinical benefit.

  7. Palbociclib safety profile [ Time Frame: 1 year ]
    Palbociclib safety profile, through the evaluation of adverse events (type, incidence, severity, timing of appearance, related causes) observed in physical explorations and laboratory tests. Toxicity will be assessed and tabulated using NCI-CTCAE 4.0.



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:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over-expression of CDK4 (mRNA expression) and a low-to-normal p16 expression (mRNA expression) measured in paraffin embedded tumor samples at study entry.
  2. ECOG 0-1 at enrollment.
  3. Diagnosis of soft tissue sarcoma or osteosarcoma (in both cases with metastasis or locally advanced, unresectable).
  4. Disease progression documented within 6 months prior to study entry.
  5. Patients must have the following laboratory results:

    • ANC ≥ 1,500/mm3 (1.5 x 109/L);
    • Platelets ≥ 100,000/mm3 (100 x 109/L);
    • Hemoglobin ≥ 9 g/dL (90 g/L);
    • Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min;
    • Total serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's disease);
    • AST and/or ALT ≤ 3 x ULN (≤ 5.0 x ULN if liver metastases present);
    • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if bone or hepatic metastasis present);
  6. Patients must have signed written informed consent to participate in the clinical study, and to provide at least two paraffin embedded tumor blocks for the molecular analyses at screening stage.
  7. Biopsy at baseline if there are no archived tumor samples obtained within 3 months prior to treatment initiation.
  8. Patients must have received standard treatments for at least one, two or three lines for advanced disease.
  9. Age between 18 and 80 years (both ages included).
  10. Measurable disease according to RECIST 1.1 criteria.
  11. All patients (men and women) in fertile age must use an effective contraception method during the entire treatment with palbociclib and for at least 90 days after the last dose. Pregnancy must be ruled out through urine or blood test (negative pregnancy test) for the inclusion in the study. Men must be informed to consider spermatic preservation before treatment initiation due to infertility risks.

Exclusion Criteria:

  1. Previous treatment with any anti CDK4 or immune checkpoint inhibitor.
  2. Diagnosis of Ewing sarcoma or rhabdomyosarcoma.
  3. Diagnosis of well differentiated/dedifferentiated liposarcoma.
  4. Patients irradiated on the only target lesion available.
  5. Patients having received more than three lines for advanced disease.
  6. History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
  7. Serious cardiovascular disease (NYHA >= 2)
  8. Grade 3 or superior toxicity according to CTCAE 4.0 if the investigator considers this can significantly interfere in the toxicity of the drug under study.
  9. Patients not recovered from a previous toxicity to at least CTCAE Grade 1 due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies).
  10. Patients not recovered from minor or major surgery or having undergone a major surgery within the last 4 weeks prior to initiation of study treatment.
  11. Central nervous system metastasis.
  12. Pregnant or breastfeeding patients, or those expecting to conceive or father children within the projected duration of treatment.
  13. Foods or drugs known as CYP3A4 inhibitors/inducers; CYP3A4 substrates with narrow therapeutic windows, or known to prolong QTc interval.
  14. Major surgery, chemotherapy, radiotherapy, any agent under investigation, or other antineoplastic therapy within 4 weeks prior to inclusion. Patients having received a previous radiotherapy ≥25% of bone marrow are not eligible, regardless of when it was received.
  15. QTc > 480 ms; personal or family history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsades de Pointes (TdP).
  16. Any of the following situations within 6 months prior to study drug administration: myocardial infarction, serious/unstable angina, current cardiac dysrhythmias Grade ≥ 2 NCI-CTCAE version 4.0, atrial fibrillation of any grade, bypass graft in coronary/peripheral artery, symptomatic congestive cardiac failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  17. Known hypersensitivity to any PD 0332991 or excipients.
  18. Active or recent suicide attempt or behavior.

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): NCT03242382


Contacts
Layout table for location contacts
Contact: Patricio Ledesma +34 971439900 ensayos@sofpromed.com
Contact: Gabriela Golab +34 648414261 ggolab@sofpromed.com

Locations
Layout table for location information
Spain
Hospital de la Santa Creu i Sant Pau Active, not recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain
Hospital Universitario Virgen de la Victoria Not yet recruiting
Málaga, Spain
Contact: Isabel Sevilla, MD         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain
Contact: Carlos Alvarez, MD         
Complejo Hospitalario Universitario de Santiago Not yet recruiting
Santiago de Compostela, Spain
Contact: Yolanda Vidal, MD         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Javier Martín Broto         
Hospital Universitari i Politècnic La Fe Not yet recruiting
Valencia, Spain
Contact: Roberto Díaz, MD         
Hospital Universitario Miguel Servet Not yet recruiting
Zaragoza, Spain
Contact: Javier Martínez Trufero, md         
Sponsors and Collaborators
Grupo Espanol de Investigacion en Sarcomas
Investigators
Layout table for investigator information
Study Director: Javier Martin Broto, MD Hospitales Universitarios Virgen del Rocío
Study Director: Roberto Díaz, MD Hospital Universitario La Fe
Principal Investigator: Javier Martínez Trufero, MD Hospital Universitario Miguel Servet
Principal Investigator: Yolanda Vidal, MD Complejo Hospitalario Universitario de Santiago
Principal Investigator: Carlos Alvarez, MD Hospital Universitario Central de Asturias
Principal Investigator: Antonio López-Pousa, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: José Antonio López-Martín, MD Hospital Universitario 12 de Octubre
Principal Investigator: Isabel Sevilla, MD Hospital Universitario Virgen de la Victoria
Layout table for additonal information
Responsible Party: Grupo Espanol de Investigacion en Sarcomas
ClinicalTrials.gov Identifier: NCT03242382    
Other Study ID Numbers: GEIS-51
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grupo Espanol de Investigacion en Sarcomas:
advanced
sarcoma
cdk4
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action