Status and phase
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About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (Cohort 1: STS and osteosarcoma):
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:
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.
Exclusion Criteria (Cohort 1: STS and osteosarcoma):
Inclusion Criteria (Cohort 2: 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:
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.
Exclusion Criteria (Cohort 2: Chordomas):
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Patricio Ledesma; Claudia Marcote
Data sourced from clinicaltrials.gov
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