AzTrials
AzTrials

Soft-tissue SarcomaPhase 2PalboSarcNCT03242382

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

A Phase 2 study testing Palbociclib in people with Soft-tissue Sarcoma and Osteosarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 19 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Soft-tissue Sarcoma, Osteosarcoma, Chordoma
What is being tested?
Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
19 sitesSpain
Study dates
31 Mar 2017to 30 Sep 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
Show all 37Show fewer
  • 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.
  • Age between 18 and 80 years (both ages included).
  • Measurable disease according to RECIST 1.1 criteria.
  • 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.
  • Mutation of CDKN2A gen.
  • ECOG 0-1 at the time of inclusion.
  • Centrally confirmed diagnosis of chordoma (metastatic or locally advanced inoperable).
  • Disease progression according to RECIST 1.1, within the year prior to inclusion, to previous treatment (surgery, radiotherapy or systemic treatment).
  • Patients are not candidates for salvage surgery or radiotherapy at the time of inclusion.
  • Patients must have the following lab results:
  • Absolute neutrophil count ≥ 1,500/mm3 (1.5 x 109/L);
  • Platelets ≥ 100,000/mm3 (100 x 109/L);
  • Hemoglobin ≥ 9 g/dL (90 g/L);
  • Blood creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min;
  • Total blood 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 there is liver metastasis);
  • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if there is bone or liver metastasis);
  • The patients must have signed the written consent to participate in the clinical study, and to provide the tumor blocks in paraffin for the molecular analysis of the screening phase.
  • Biopsy at baseline if there are no archive tumor samples obtained in the 3 months prior to starting treatment. If there are tumor samples within this period, there should not be subsequent treatments.
  • Patients may have received up to 3 previous lines of systemic treatment.
  • Age between 18 and 80 years (both ages included).
  • Measurable disease according to RECIST 1.1 criteria.
  • All patients (male and female) of childbearing potential must use effective contraception throughout treatment with palbociclib and for at least 90 days after the last dose. Pregnancy must be ruled out by urine or blood test (negative pregnancy test) for inclusion in the study. Men should be told to consider sperm preservation before starting treatment due to the risks of infertility.

Who cannot join

  • 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.
Show all 35Show fewer
  • 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.
  • 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.
  • 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.
  • Known hypersensitivity to any PD 0332991 or excipients.
  • Active or recent suicide attempt or behavior.
  • Prior treatment with any anti-CDK4 or immune checkpoint inhibitors.
  • Diagnosis other than chordoma according to central review.
  • Patients irradiated in the only available target lesion.
  • Patients who have received more than three lines for advanced disease.
  • History of other neoplastic disease with the exception of adequately treated basal cell carcinoma or cervical cancer in situ. This criterion will be individually assessed with the research team.
  • Severe cardiovascular disease (NYHA >= 2).
  • Grade 3 toxicity or higher according to CTCAE 5.0 if, in the investigator's opinion, it can significantly interfere with the toxicity of the drug under study.
  • Patients who have not recovered from previous toxicity up to CTCAE grade 1 due to previous antineoplastic treatment with chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies).
  • Patients who have not recovered from minor or major surgery or who have had major surgery within 4 weeks prior to the start of study treatment.
  • Metastases in the central nervous system.
  • Patients who are pregnant or lactating, or who expect to conceive children during the treatment period.
  • Foods or drugs known to be inhibitors/inducers of CYP3A4; CYP3A4 substrates with narrow therapeutic windows, or known to prolong the QTc interval.
  • Major surgery, chemotherapy, radiation therapy, any investigational agent, or other antineoplastic therapy within 4 weeks prior to enrollment. Patients who have received prior radiation therapy to ≥25% of the bone marrow are not eligible, regardless of when received.
  • 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 within 6 months prior to study drug administration: Myocardial infarction, severe/unstable angina, current NCI-CTCAE version 5.0 Grade ≥ 2 cardiac dysrhythmias, any grade atrial fibrillation, implant coronary/peripheral artery pacemaker, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, symptomatic pulmonary embolism, or interstitial lung disease (ILD).
  • Known hypersensitivity to any PD 0332991 or excipients.
  • Active or recent suicidal intent or behavior.

Trial locations and contacts

19 sites in 1 country.

Patricio Ledesma contact

+34 971439900

ensayos@sofpromed.com

Claudia Marcote contact

+34 660570948

cmarcote@sofpromed.com

19 sites in 1 country

Spain19 sites, 19 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Antonio Lopez-Pousa, MD

    Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Barcelona

    Anna Estival

    Recruiting

  • Institut Català d'Oncología l'Hospitalet

    Barcelona

    Xavier García del Muro

    Recruiting

  • Complejo Asistencial Universitario de León

    León

    Luís Miguel de Sande

    Recruiting

  • Hospital Clínico San Carlos

    Madrid

    Antonio Casado

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid

    Rosa Álvarez

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Diego Jara, MD

    Recruiting

  • Hospital Universitario Fundación Jimenez Diaz

    Madrid

    Javier Martín Broto

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Andrés Redondo

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga

    Isabel Sevilla, MD

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia

    Jerónimo Martínez

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo

    Juan Luís García Llanos, MD

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca

    Pablo Luna

    Recruiting

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

    Josefina Cruz

    Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

    Yolanda Vidal, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Irene Carrasco García

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia

    Roberto Díaz, MD

    Recruiting

  • Instituto Valenciano de Oncología

    Valencia

    Javier Lavernia

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza

    Javier Martínez Trufero, md

    Recruiting

Other trials in Spain

About this study

Official title: Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.

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.

Being tested
Palbociclib
Keywords
advanced, sarcoma, cdk4
Medical subject headings
Sarcoma, Osteosarcoma, Chordoma

What participants receive

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

  • PalbociclibDrug

    Also called Ibrance

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

Study groups in NCT03242382
Study groupRoleWhat they receive
PalbocilibExperimentalPalbociclib 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.
Receives: Drug: Palbociclib

What is being measured

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

  1. Progression free survival (PFS) rate

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

    Measured: At 6 months

Secondary outcomes (7)

  1. Overall response rate (ORR)

    Efficacy measured through the overall 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.

    Measured: 6 months

  2. Efficacy measured through response according to Choi criteria measured through response according to Choi criteria:

    Efficacy measured 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.

    Measured: 6 months

  3. Efficacy measured through median PFS

    Efficacy measured through median PFS.

    Measured: 6 months

  4. Efficacy measured through PFS rate at 3 months

    Efficacy measured through PFS rate at 3 months.

    Measured: 3 months

  5. Overall survival (OS)

    Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.

    Measured: 2 years

  6. Clinical Benefit Rate (CBR)

    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.

    Measured: 6 months

  7. Palbociclib safety profile

    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 (first cohort; STS and osteosarcoma) and 5.0 (second cohort; chordomas).

    Measured: 1 year

Timeline

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

  1. First posted8 Aug 2017
  2. Study start31 Mar 2017
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242382
Sponsor's protocol ID
GEIS-51
Acronym
PalboSarc
Status last verified
Jan 2024
First submitted
3 Aug 2017
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib in people with Soft-tissue Sarcoma and Osteosarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 19 sites in Spain.

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 37 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. 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?

Results are not available in the source record.

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

Contact Patricio Ledesma (+34 971439900, ensayos@sofpromed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) rate (time frame: At 6 months). 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 NCT03242382.

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 23 Jan 2024.

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