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NCT03632135: CSCRGBM

Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma

Completed Phase 3 Results posted Last updated 15 April 2025
What this trial tests

Phase 3 trial testing ChemoID assay in Recurrent Glioblastoma in 78 participants. Completed in 31 December 2023.

Timeline
20 May 2018
Primary endpoint
16 June 2022
31 December 2023

Quick facts

Lead sponsorCordgenics, LLC
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposediagnostic
Enrollment78
Start date20 May 2018
Primary completion16 June 2022
Estimated completion31 December 2023
Sites13 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cordgenics, LLC

Who can join

18 and older, any sex, with Recurrent Glioblastoma. 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.

Median Overall Survival (OS) Primary · 36 months

Overall survival (OS) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

GroupValue95% CI
Physician Choice Treatment7.53.5 – 11.5
ChemoID-guided Treatment1210.8 – 13.2
Median Progression Free Survival (PFS) Secondary · 36 months

Median Progression Free Survival in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

GroupValue95% CI
Physician Choice Treatment3.51.9 – 5.1
ChemoID-guided Treatment10.14.8 – 15.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Physician Choice Treatment
Serious: 12/35 (34%)
Deaths: 35/35
ChemoID-guided Treatment
Serious: 18/43 (42%)
Deaths: 43/43

Serious adverse events (7 terms)

ReactionSystemPhysician Choice TreatmentChemoID-guided Treatment
Low White blood cell countBlood and lymphatic system disorders
Low platelet countBlood and lymphatic system disorders
ALT increasedHepatobiliary disorders
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
ThromboemboliaVascular disorders
Muscle WeaknessMusculoskeletal and connective tissue disorders
Other adverse events (12 terms — click to expand)

ReactionSystemPhysician Choice TreatmentChemoID-guided Treatment
Low white blood cells countBlood and lymphatic system disorders
FatigueGeneral disorders
Platelet count decreasedBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
NeuropathyNervous system disorders
NauseaGeneral disorders
Decreased hemoglobinBlood and lymphatic system disorders
AnorexiaGeneral disorders
weight lossGeneral disorders
SeizureNervous system disorders
HemorrhageVascular disorders
weaknessGeneral disorders

Most-reported serious reactions: Low White blood cell count, Low platelet count, ALT increased, Anemia, Diarrhea, Thromboembolia, Muscle Weakness.

Data from ClinicalTrials.gov NCT03632135 adverse events section.

Sponsor's own description

The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

Publications & conference data

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

  1. Cancer stem cells: advances in knowledge and implications for cancer therapy.
    Chu X, Tian W, Ning J, Xiao G, et al · · 2024 · cited 311× · PMID 38965243 · DOI 10.1038/s41392-024-01851-y
  2. Tumor microenvironment enriches the stemness features: the architectural event of therapy resistance and metastasis.
    Nallasamy P, Nimmakayala RK, Parte S, Are AC, et al · · 2022 · cited 163× · PMID 36550571 · DOI 10.1186/s12943-022-01682-x
  3. Glioblastoma Therapy: Past, Present and Future.
    Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529
  4. Recurrent Glioblastoma: From Molecular Landscape to New Treatment Perspectives.
    Birzu C, French P, Caccese M, Cerretti G, et al · · 2020 · cited 141× · PMID 33375286 · DOI 10.3390/cancers13010047
  5. Treatment options for progression or recurrence of glioblastoma: a network meta-analysis.
    McBain C, Lawrie TA, Rogozińska E, Kernohan A, et al · · 2021 · cited 105× · PMID 34559423 · DOI 10.1002/14651858.cd013579.pub2
  6. The adaptive transition of glioblastoma stem cells and its implications on treatments.
    Wang Z, Zhang H, Xu S, Liu Z, et al · · 2021 · cited 101× · PMID 33753720 · DOI 10.1038/s41392-021-00491-w
  7. Advances in Therapeutic Targeting of Cancer Stem Cells within the Tumor Microenvironment: An Updated Review.
    Dzobo K, Senthebane DA, Ganz C, Thomford NE, et al · · 2020 · cited 86× · PMID 32823711 · DOI 10.3390/cells9081896
  8. Drug resistance in cancer therapy: the Pandora's Box of cancer stem cells.
    Rezayatmand H, Razmkhah M, Razeghian-Jahromi I. · · 2022 · cited 82× · PMID 35505363 · DOI 10.1186/s13287-022-02856-6

Verify or expand the search:

Other trials of ChemoID assay

Trials testing the same drug.

Other recruiting trials for Recurrent Glioblastoma

Currently open trials in the same condition.

Other Cordgenics, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03632135.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing