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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Grupo Espanol de Investigacion en Sarcomas
Updated on 18 June 2022
absolute neutrophil count
measurable disease
serum bilirubin
gilbert's disease
metastasis
neutrophil count
liver metastasis
palbociclib
sarcoma
soft tissue sarcoma

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.

Details
Condition Soft-tissue Sarcoma, Osteosarcoma, Chordoma
Treatment Palbociclib
Clinical Study IdentifierNCT03242382
SponsorGrupo Espanol de Investigacion en Sarcomas
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Chordomas)
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
Age between 18 and 80 years (both ages included)
of the screening phase
Measurable disease according to RECIST 1.1 criteria
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
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

Exclusion Criteria

Chordomas)
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
Known hypersensitivity to any PD 0332991 or excipients
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)
Active or recent suicidal intent or behavior
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