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

NCT03242382 | Unknown Phase 2

• 1 other identifier: GEIS-51
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 19

Brief Summary

Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in Spain. Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes chordoma patients only (19 patients). 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.

Conditions

Soft-tissue Sarcoma; Osteosarcoma; Chordoma

Keywords

advanced; sarcoma; cdk4

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) rate

  Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.

  At 6 months

Secondary Outcomes (7)

• Overall response rate (ORR)

  6 months

• Efficacy measured through response according to Choi criteria measured through response according to Choi criteria:

  6 months

• Efficacy measured through median PFS

  6 months

• Efficacy measured through PFS rate at 3 months

  3 months

• Overall survival (OS)

  2 years

Study Arms (1)

Palbocilib

EXPERIMENTAL

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

Interventions

Palbociclib DRUG

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

Also known as: Ibrance

Palbocilib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over-expression of CDK4 (mRNA expression) and a low-to-normal p16 expression (mRNA expression) measured in paraffin embedded tumor samples at study entry.
• ECOG 0-1 at enrollment.
• Diagnosis of soft tissue sarcoma or osteosarcoma (in both cases with metastasis or locally advanced, unresectable).
• Disease progression documented within 6 months prior to study entry.
• 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);
• 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.
• Biopsy at baseline if there are no archived tumor samples obtained within 3 months prior to treatment initiation.
• Patients must have received standard treatments for at least one, two or three lines for advanced disease.

You may not qualify if:

• Previous treatment with any anti CDK4 or immune checkpoint inhibitor.
• Diagnosis of Ewing sarcoma or rhabdomyosarcoma.
• Diagnosis of well differentiated/dedifferentiated liposarcoma.
• Patients irradiated on the only target lesion available.
• Patients having received more than three lines for advanced disease.
• History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
• Serious cardiovascular disease (NYHA \>= 2)
• 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.
• 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).
• 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.
• Central nervous system metastasis.
• Pregnant or breastfeeding patients, or those expecting to conceive or father children within the projected duration of treatment.
• Foods or drugs known as CYP3A4 inhibitors/inducers; CYP3A4 substrates with narrow therapeutic windows, or known to prolong QTc interval.
• 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).
• 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.

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas: lead

Study Sites (19)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

RECRUITING

Institut Català d'Oncología l'Hospitalet

Barcelona, Spain

RECRUITING

Complejo Asistencial Universitario de León

León, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Jimenez Diaz

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Chordoma

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Germ Cell and Embryonal

Study Officials

• Irene Carrasco García, MD

  Hospitales Universitarios Virgen del Rocío

  STUDY DIRECTOR

• Roberto Díaz, MD

  Hospital Universitario La Fe

  STUDY DIRECTOR

• Javier Martínez Trufero, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Yolanda Vidal, MD

  Complejo Hospitalario Universitario de Santiago

  PRINCIPAL INVESTIGATOR

• Juan Luís García Llano, 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

• Diego Jara, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Isabel Sevilla, MD

  Hospital Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

• Javier Martín Broto

  Hospital Universitario Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

• Anna Estival

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Luís Miguel de Sande

  Complejo Asistencial Universitario de León

  PRINCIPAL INVESTIGATOR

• Rosa Álvarez

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Claudia Valverde

  Hospital Universitari Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

• Andrés Redondo

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Josefina Cruz

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

• Javier Lavernia

  Instituto Valenciano de Oncología

  PRINCIPAL INVESTIGATOR

• Pablo Luna

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Jerónimo Martínez

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

• Xavier García del Muro

  Institut Català d'Oncología l'Hospitalet

  PRINCIPAL INVESTIGATOR

• Antonio Casado

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricio Ledesma

CONTACT

+34 971439900; ensayos@sofpromed.com

Claudia Marcote

CONTACT

+34 660570948; cmarcote@sofpromed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 8, 2017
• Study Start: March 31, 2017
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

ES (19)