TriangleNCT02465528 · STUDY IN CONTEXT
Ceritinib Rare Indications Study in ALK+ Tumors
Draft scope assessment: unclear. Attached because the study's own record names ALK and names ALK. The study record does not state Positive, positive, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause
Deaths due to any cause during treatment and 30 day follow-up
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- trial label
- Ceritinib Rare Indications Study in ALK+ Tumors
- applicability
- unclear
- applicability note
- Attached because the study's own record names ALK and names ALK. The study record does not state Positive, positive, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0000
- source section id
- NCT02465528-om-0000
- source outcome index
- 0
- endpoint
- Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
- endpoint definition
- The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
- time origin
- Baseline up to approximately 16 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0001
- source section id
- NCT02465528-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate (ORR) Per Investigator Assessment
- endpoint definition
- ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
- time origin
- Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0002
- source section id
- NCT02465528-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response (DOR) Per Investigator Assessment
- endpoint definition
- DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
- time origin
- Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0003
- source section id
- NCT02465528-om-0003
- source outcome index
- 3
- endpoint
- Time to Response (TTR) Per Investigator Assessment
- endpoint definition
- TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
- time origin
- Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0004
- source section id
- NCT02465528-om-0004
- source outcome index
- 4
- endpoint
- Progression Free Survival (PFS) Per Investigator Assessments
- endpoint definition
- PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause
- time origin
- Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- no participants met definition of PFS
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0005
- source section id
- NCT02465528-om-0005
- source outcome index
- 5
- endpoint
- Percent of Participant Deaths During Treatment and Follow-up
- endpoint definition
- Deaths due to any cause during treatment and 30 day follow-up
- time origin
- Baseline up to approximately 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were no deaths in the ALCL and IMT arms
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Anaplastic Large Cell Lymphoma (ALCL)
- regimen
- Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Inflammatory Myofibroblastic Tumor (IMT)
- regimen
- Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Glioblastoma (GBM)
- regimen
- Patients with GBM with a translocation involving the ALK gene
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Any Other ALK-positive Tumor
- regimen
- Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Anaplastic Large Cell Lymphoma (ALCL)
- regimen
- Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Inflammatory Myofibroblastic Tumor (IMT)
- regimen
- Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Glioblastoma (GBM)
- regimen
- Patients with GBM with a translocation involving the ALK gene
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Any Other ALK-positive Tumor
- regimen
- Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Anaplastic Large Cell Lymphoma (ALCL)
- regimen
- Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Inflammatory Myofibroblastic Tumor (IMT)
- regimen
- Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Glioblastomia (GBM)
- regimen
- Patients with GBM with a translocation involving the ALK gene
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Any Other ALK-positive Tumor
- regimen
- Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02465528-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- harm key
- EG000
- source section id
- NCT02465528-ae
- event group key
- EG000
- event group label
- Anaplastic Large Cell Lymphoma
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
- event definition
- Any sign or symptom that occured during the study treatment plus 30 days post treatment
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- harm key
- EG001
- source section id
- NCT02465528-ae
- event group key
- EG001
- event group label
- Inflammatory Myofibroblastic Tumor
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
- event definition
- Any sign or symptom that occured during the study treatment plus 30 days post treatment
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- harm key
- EG002
- source section id
- NCT02465528-ae
- event group key
- EG002
- event group label
- Glioblastoma
- serious affected
- 10
- serious at risk
- 12
- other affected
- 12
- other at risk
- 12
- frequency threshold
- 5
- collection period
- Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
- event definition
- Any sign or symptom that occured during the study treatment plus 30 days post treatment
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- harm key
- EG003
- source section id
- NCT02465528-ae
- event group key
- EG003
- event group label
- Any Other ALK+ Tumor
- serious affected
- 4
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
- event definition
- Any sign or symptom that occured during the study treatment plus 30 days post treatment
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-inflammatory-myofibroblastic-tumor-xalkori-62f77c93
- nct id
- NCT02465528
- harm key
- EG004
- source section id
- NCT02465528-ae
- event group key
- EG004
- event group label
- All Subjects
- serious affected
- 16
- serious at risk
- 22
- other affected
- 22
- other at risk
- 22
- frequency threshold
- 5
- collection period
- Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
- event definition
- Any sign or symptom that occured during the study treatment plus 30 days post treatment
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice