AG-120 in People With IDH1 Mutant Chondrosarcoma

  • STATUS
    Recruiting
  • End date
    Mar 12, 2023
  • participants needed
    17
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 12 May 2022
cancer
measurable disease
kidney function tests
neutrophil count

Summary

This study is being done to see whether AG-120 is an effective and safe treatment for people with advanced/metastatic or recurrent chondrosarcoma that has IDH1 mutation.

Details
Condition Chondrosarcoma, Chondrosarcoma, Grade 2, Chondrosarcoma, Grade 3, IDH1 Gene Mutation
Treatment AG-120
Clinical Study IdentifierNCT04278781
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be >/= 18 years of age
Have a histological diagnosis (fresh or archived tumor biopsy sample) of locally advanced/metastatic or recurrent operable chondrosarcoma (conventional grade 2 or 3 only) confirmed by central pathology review
Patients with low grade (grade 1) and dedifferentiated chondrosarcoma are ineligible
Patients with biopsy proven low grade (grade 1) pelvic chondrosarcoma are ineligible unless they have radiological imaging consistent with higher grade disease in which case they will be deemed potentially eligible. In such cases the pre-treatment biopsy should be taken where feasible from the area of presumed higher-grade disease to confirm grade 2 or 3 disease to confirm eligibility
Patients without confirmation of grade 2 or 3 disease will not be eligible for the study unless in the case where radiology features are consistent with high grade disease but a biopsy confirmation of this is not technically feasible. Such cases should be discussed with the principal investigator before enrollment onto the study
Have a documented IDH1 gene mutation (from a fresh tumor biopsy or from archived tumor
Have an ECOG OS score of 0 to 2
tissue) confirmed by a CLIA approved laboratory
Have expected survival of >/= 4 months
Have at least one measurable lesion as defined by RECIST 1.1, subjected who have received prior local therapy are eligible provided the measurable disease falls outside of the treatment field or within the field and has shown >/=20% growth in size since post-treatment assessment
Have documented radiographic disease progression within the preceding 4 months before study entry (date ICF signed)
Have recovered from toxicities associated with prior anti-cancer therapy to baseline unless
stabilized under medical management (see washout time from different therapies in Exclusion
Have adequate bone marrow functions as evidenced by
Criteria section)
Absolute neutrophil count >/=1,500/mm^3 or 100 x 10^9/L
Hemoglobin >/=8/dL
Platelets >/=100,000/mm^3 or 100 x 10^9/L
Have adequate hepatic function as evidenced by
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </=5 x ULN
Serum total bilirubin </=2 x upper limit of normal (ULN), unless considered due
Have adequate renal function as evidenced by
to Gilbert's disease
Serum creatinine <1.5 x ULN OR
(140 Age) x (weight in kg) x (0.85 if female)/72 x serum creatinine
creatinine clearance >/= 50ml/min based on the cockcroft-gault glomerular
Be able to swallow oral medication
filtration rate (GFR) estimation
Be able to understand and willing to sign the informed consent form and to comply with
scheduled visits, treatment plans, procedures and laboratory tests, including serial
peripheral blood sampling and urine sampling, during the study. A legally authorized
representative may consent on behalf of a subject who is otherwise unable to provide
informed consent if acceptable to and approved by the site's Institutional Review
Board (IRB)
Female subjects with reproductive potential must have a negative serum or urine
pregnancy test prior to the start of therapy, or a confirmation from an obstetrician
in case of equivocal serum pregnancy results. Females of reproductive potential are
defined as sexually mature women who have not undergone a hysterectomy, bilateral
oophorectomy, or tubal occlusion or who have not been naturally postmenopausal (i.e
who have not menstruated) for at least 24 consecutive months (i.e., have not had
menses at any time in the preceding 24 consecutive months). Women of reproductive
potential, as well as fertile men and their partners who are female with reproductive
potential, must agree to use 2 effective forms of contraception (including at least 1
barrier form) from the time of giving informed consent throughout the study and for 90
days (both females and males) following the last dose of study drug. Effective forms
of contraception are defined as hormonal oral contraceptive, injectables, patches
intrauterine devices, intrauterine hormone-releasing systems bilateral tubal ligation
condoms with spermicide, or male partner sterilization

Exclusion Criteria

Received a prior IDH1 inhibitor
Note: up to 10mg per day of prednisolone or equivalent will be allowed
Has another concurrent active cancer requiring therapeutic intervention
Are pregnant or breastfeeding
Have any known hypersensitivity to any components of AG-120
Has a known medical history of progressive multifocal leukoencephalopathy (PML)
Received systemic anticancer therapy or an investigational agent < 3 week prior to the
Day 1 (washout from prior immune based anticancer therapy is 4 weeks)
Received radiotherapy or other local intervention to metastatic sites of disease <2
weeks prior to Day 1
Underwent major surgery within 4 weeks of Day 1 or have not recovered from clinically
significant post-surgery toxicities
Have known symptomatic brain metastasis requiring steroids. Subject with previously
diagnosed brain metastases are eligible if they completed their treatment and have
recovered from the acute effects of radiation therapy or surgery prior to study entry
have discontinued corticosteroid treatment for these metastases for at least 4 weeks
and have a radiographically stable disease for a least 3 months prior to study entry
Are taking known strong CYP3A4 inducers or sensitive CYP3A4 substrate medications with
a narrow therapeutic window unless they can be transferred to other medication within
>/=5 half-lives prior to dosing
Are taking p-glycoprotein (P-gp) transporter-sensitive substrate medications with a
narrow therapeutic window, unless they can be transferred to other medications within
>/= half-lives prior to dosing, or unless the medications can be properly monitored
during the study
Have an active infection requiring systemic anti-infective therapy or with an
unexplained fever > 38.5 degrees C within 7 days of Day 1 (at the discretion of the
investigator, subjects with tumor fever may be enrolled)
Have significant active cardiac disease within 6 months prior to the start of study
treatment, including New York Heart Association Class II or IV congestive heart
failure: myocardial infraction: unstable angina; and/or stroke
Have LVEP <40% by ECHO and/or MUGA scan obtained within 28 days prior to the start of
the study treatment
Have a heart-rate corrected QT interval [using Frederica's Formula] (QTcF) >/=450msec
or other factor that increase the risk of QT prolongation or arrhythmic events (e.g
heart failure, hypokalemia, family history of long QT interval syndrome). Bundle
branch block and prolonged QTcF interval are permitted with approval of the principal
investigator
Are taking medications known to prolong the QT interval, unless they can have
transferred to other medications within >/= half-lives prior to dosing, or unless the
medications can be properly monitored during the study (If equivalent medication is
not available, QTcF should be closely monitored)
Have known active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive
human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency
syndrome (AIDS) related illness. Subjects with a sustained viral response to HCV or
immunity to prior HBV infection will be permitted. Subjects with chronic HBV that is
adequately suppressed per institutional practice will be permitted
Have any other acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or a laboratory abnormality that may increase
the risk associated with study participation or investigational product administration
or may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study
Have known active inflammatory gastrointestinal disease, previous gastric resection
or lap band dysphagia, short bowel syndrome, gastroparesis or other conditions that
limit ingestion or gastrointestinal absorption of drugs administered orally
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