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NCT01653028

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Completed Phase 2 Results posted Last updated 30 November 2017
What this trial tests

Phase 2 trial testing Alisertib in Myxofibrosarcoma in 72 participants. Completed.

Timeline
22 August 2012
Primary endpoint
2 August 2015

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment72
Start date22 August 2012
Primary completion2 August 2015
Sites235 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Myxofibrosarcoma or Recurrent Adult Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. Primary · Up to 18 months

The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for fur

GroupValue95% CI
Cohort 10
Cohort 20
Cohort 30
Cohort 40
Cohort 57
Overall Survival (OS) Secondary · The time between registration and death, assessed up to 18 months

The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).

GroupValue95% CI
Cohort 1NA23.3 – NA
Cohort 271.716 – NA
Cohort 367.819 – NA
Cohort 46916 – NA
Cohort 528.616.6 – 51.3
Progression Free Survival (PFS) Secondary · The time between registration to disease progression or death, assessed up to 18 months

The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).

GroupValue95% CI
Cohort 1136.29 – 37.1
Cohort 211.71.71 – 21.9
Cohort 311.75 – 20.6
Cohort 413.23.57 – 45
Cohort 56.575.86 – 18.1
Adverse Events Secondary · During treatment and up to 5 years

Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.

Grade 4 Event
GroupValue95% CI
Cohort 16
Cohort 21
Cohort 35
Cohort 40
Cohort 54
Grade 5 Event
GroupValue95% CI
Cohort 10
Cohort 20
Cohort 30
Cohort 40
Cohort 50

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1
Serious: 2/12 (17%)
Deaths: —
Cohort 2
Serious: 2/10 (20%)
Deaths: —
Cohort 3
Serious: 1/11 (9%)
Deaths: —
Cohort4
Serious: 4/10 (40%)
Deaths: —
Cohort 5
Serious: 13/29 (45%)
Deaths: —

Serious adverse events (30 terms)

ReactionSystemCohort 1Cohort 2Cohort 3Cohort4Cohort 5
VomitingGastrointestinal disorders—————
Neutrophil count decreasedInvestigations—————
Febrile neutropeniaBlood and lymphatic system disorders—————
DiarrheaGastrointestinal disorders—————
Mucositis oralGastrointestinal disorders—————
NauseaGastrointestinal disorders—————
Lung infectionInfections and infestations—————
Platelet count decreasedInvestigations—————
Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders—————
Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders—————
AnemiaBlood and lymphatic system disorders—————
Abdominal painGastrointestinal disorders—————
Colonic fistulaGastrointestinal disorders—————
Duodenal obstructionGastrointestinal disorders—————
TyphlitisGastrointestinal disorders—————
FatigueGeneral disorders—————
SepsisInfections and infestations—————
Wound infectionInfections and infestations—————
Blood bilirubin increasedInvestigations—————
INR increasedInvestigations—————
Serum amylase increasedInvestigations—————
White blood cell decreasedInvestigations—————
AnorexiaMetabolism and nutrition disorders—————
DehydrationMetabolism and nutrition disorders—————
HyperkalemiaMetabolism and nutrition disorders—————
Other adverse events (121 terms — click to expand)

ReactionSystemCohort 1Cohort 2Cohort 3Cohort4Cohort 5
Neutrophil count decreasedInvestigations—————
AlopeciaSkin and subcutaneous tissue disorders—————
AnemiaBlood and lymphatic system disorders—————
Platelet count decreasedInvestigations—————
FatigueGeneral disorders—————
White blood cell decreasedInvestigations—————
DiarrheaGastrointestinal disorders—————
Mucositis oralGastrointestinal disorders—————
NauseaGastrointestinal disorders—————
Lymphocyte count decreasedInvestigations—————
SomnolenceNervous system disorders—————
VomitingGastrointestinal disorders—————
Alkaline phosphatase increasedInvestigations—————
Aspartate aminotransferase increasedInvestigations—————
AnorexiaMetabolism and nutrition disorders—————
HyponatremiaMetabolism and nutrition disorders—————
PruritusSkin and subcutaneous tissue disorders—————
ConstipationGastrointestinal disorders—————
HyperglycemiaMetabolism and nutrition disorders—————
HypoalbuminemiaMetabolism and nutrition disorders—————
Peripheral sensory neuropathyNervous system disorders—————
CoughRespiratory, thoracic and mediastinal disorders—————
Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders—————
Rash maculo-papularSkin and subcutaneous tissue disorders—————
Febrile neutropeniaBlood and lymphatic system disorders—————
Blurred visionEye disorders—————
DysphagiaGastrointestinal disorders—————
ChillsGeneral disorders—————
FeverGeneral disorders—————
PainGeneral disorders—————
Alanine aminotransferase increasedInvestigations—————
Blood bilirubin increasedInvestigations—————
Creatinine increasedInvestigations—————
HypocalcemiaMetabolism and nutrition disorders—————
HypokalemiaMetabolism and nutrition disorders—————
Back painMusculoskeletal and connective tissue disorders—————
Musculoskeletal and connective tissue disorder - Other, specifyMusculoskeletal and connective tissue disorders—————
ConfusionPsychiatric disorders—————
DyspneaRespiratory, thoracic and mediastinal disorders—————
LeukocytosisBlood and lymphatic system disorders—————

Most-reported serious reactions: Vomiting, Neutrophil count decreased, Febrile neutropenia, Diarrhea, Mucositis oral, Nausea, Lung infection, Platelet count decreased.

Data from ClinicalTrials.gov NCT01653028 adverse events section.

Sponsor's own description

This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapeutic targeting of "undruggable" MYC.
    Llombart V, Mansour MR. · · 2022 · cited 349× · PMID 34942444 · DOI 10.1016/j.ebiom.2021.103756
  2. The two sides of chromosomal instability: drivers and brakes in cancer.
    Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
  3. Phase II study of MLN8237 (Alisertib) in advanced/metastatic sarcoma.
    Dickson MA, Mahoney MR, Tap WD, D'Angelo SP, et al · · 2016 · cited 88× · PMID 27502708 · DOI 10.1093/annonc/mdw281
  4. Emerging roles of Aurora-A kinase in cancer therapy resistance.
    Zheng D, Li J, Yan H, Zhang G, et al · · 2023 · cited 71× · PMID 37521867 · DOI 10.1016/j.apsb.2023.03.013
  5. Second-Generation Antimitotics in Cancer Clinical Trials.
    Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
  6. Targeting Myc-driven stress addiction in colorectal cancer.
    Saeed H, Leibowitz BJ, Zhang L, Yu J. · · 2023 · cited 35× · PMID 37119690 · DOI 10.1016/j.drup.2023.100963
  7. Comprehensive analysis of published studies involving systemic treatment for chondrosarcoma of bone between 2000 and 2013.
    van Maldegem AM, Bovée JV, Gelderblom H. · · 2014 · cited 23× · PMID 25126409 · DOI 10.1186/2045-3329-4-11
  8. The Role of FBXW7 in Gynecologic Malignancies.
    Di Fiore R, Suleiman S, Drago-Ferrante R, Subbannayya Y, et al · · 2023 · cited 13× · PMID 37408248 · DOI 10.3390/cells12101415

Verify or expand the search:

Other trials of Alisertib

Trials testing the same drug.

Other recruiting trials for Myxofibrosarcoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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