Ceritinib Rare Indications Study in ALK+ Tumors
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT02465528
Collaborator
(none)
22
14
4
27.5
1.6
0.1
Study Details
Study Description
Brief Summary
This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Depending on the tumor type, subjects were to be enrolled into one of the following parallel arms: ALCL (anaplastic large cell lymphoma); IMT (inflammatory myofibroblastic tumor); glioblastoma (GBM), and any other ALK+ tumor. If there were 5 or more subjects of the same tumor type in the "Any other ALK+ tumor" arm, then a separate arm was to be opened for that specific tumor type.Depending on the tumor type, subjects were to be enrolled into one of the following parallel arms: ALCL (anaplastic large cell lymphoma); IMT (inflammatory myofibroblastic tumor); glioblastoma (GBM), and any other ALK+ tumor. If there were 5 or more subjects of the same tumor type in the "Any other ALK+ tumor" arm, then a separate arm was to be opened for that specific tumor type.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)
Actual Study Start Date
:
May 6, 2016
Actual Primary Completion Date
:
Aug 20, 2018
Actual Study Completion Date
:
Aug 20, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inflammatory myofibroblastic tumor (IMT) Patients diagnosed with IMT with a confirmed translocation involving the ALK gene |
Drug: Ceritinib (LDK378)
Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
|
| Experimental: Anaplastic large cell lymphoma (ALCL) Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive |
Drug: Ceritinib (LDK378)
Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
|
| Experimental: Glioblastoma (GBM) Patients with GBM with a translocation involving the ALK gene |
Drug: Ceritinib (LDK378)
Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
|
| Experimental: Any other ALK-positive tumor Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
Drug: Ceritinib (LDK378)
Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
|
Outcome Measures
Primary Outcome Measures
- Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment [Baseline up to approximately 16 weeks]
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).
Secondary Outcome Measures
- Overall Response Rate (ORR) Per Investigator Assessment [Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks]
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.
- Duration of Response (DOR) Per Investigator Assessment [Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks]
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 to Response (TTR) Per Investigator Assessment [Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks]
TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
- Progression Free Survival (PFS) Per Investigator Assessments [Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks]
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
- Percent of Participant Deaths During Treatment and Follow-up [Baseline up to approximately 84 weeks]
Deaths due to any cause during treatment and 30 day follow-up
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) tumor other than Non-Small Cell Lung Cancer (NSCLC).
-
Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory.
-
Patient has WHO Performance Status (PS) ≤ 2
-
Patient must have received at least one line of prior systemic treatment for recurrent, locally advanced and/or metastatic disease, and may have discontinued for:
-
Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM and by Cheson assessment criteria for lymphoma, or
-
Intolerance described as any discontinuation due to an AE of any grade despite appropriate supportive treatment
-
Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
-
Patient has received no chemotherapy, immunotherapy or stem cell therapy at least 4 weeks before starting ceritinib
-
Radiotherapy and prior ALK inhibitors must be stopped at least 1 week prior to starting ceritinib
-
Recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v4.03).
Exclusion Criteria:
-
Patient has ALK+lung cancer
-
Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
-
Patient with acute or chronic GI disease that may significantly alter the absorption of ceritinib.
-
Patient with a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
-
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
-
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).
-
Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing for viral hepatitis is not mandatory).
-
Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Brno | Czech Republic | Czechia | 656 53 |
| 2 | Novartis Investigative Site | Copenhagen | Denmark | DK-2100 | |
| 3 | Novartis Investigative Site | Lyon Cedex | France | 69373 | |
| 4 | Novartis Investigative Site | Saint-Herblain Cédex | France | 44805 | |
| 5 | Novartis Investigative Site | Strasbourg | France | F 67085 | |
| 6 | Novartis Investigative Site | Tel Aviv | Israel | 6423906 | |
| 7 | Novartis Investigative Site | Milano | MI | Italy | 20133 |
| 8 | Novartis Investigative Site | Seoul | Korea, Republic of | 03080 | |
| 9 | Novartis Investigative Site | Seoul | Korea, Republic of | 03722 | |
| 10 | Novartis Investigative Site | Seoul | Korea, Republic of | 06351 | |
| 11 | Novartis Investigative Site | Madrid | Spain | 28034 | |
| 12 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 13 | Novartis Investigative Site | Bangkok | Thailand | 10330 | |
| 14 | Novartis Investigative Site | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02465528
Other Study ID Numbers:
- CLDK378A2407
First Posted:
Jun 8, 2015
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A minimum of 10 and a maximum of 20 subjects were to be enrolled in each arm (tumor type) |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Period Title: Overall Study | ||||
| STARTED | 1 | 4 | 12 | 5 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 4 | 12 | 5 |
Baseline Characteristics
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). | Total of all reporting groups |
| Overall Participants | 1 | 4 | 12 | 5 | 22 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
36.0
|
42.8
(19.41)
|
49.3
(15.40)
|
57.4
(14.64)
|
49.3
(15.85)
|
| Age, Customized (Count of Participants) | |||||
| 18 to <65 |
1
100%
|
4
100%
|
10
83.3%
|
3
60%
|
18
81.8%
|
| 65 to <=75 |
0
0%
|
0
0%
|
2
16.7%
|
2
40%
|
4
18.2%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
100%
|
3
75%
|
6
50%
|
1
20%
|
11
50%
|
| Male |
0
0%
|
1
25%
|
6
50%
|
4
80%
|
11
50%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| Caucasian |
0
0%
|
1
25%
|
10
83.3%
|
2
40%
|
13
59.1%
|
| Asian |
1
100%
|
1
25%
|
1
8.3%
|
3
60%
|
6
27.3%
|
| Other |
0
0%
|
2
50%
|
1
8.3%
|
0
0%
|
3
13.6%
|
Outcome Measures
| Title | Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment |
|---|---|
| Description | 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 Frame | Baseline up to approximately 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 1 | 4 | 12 | 5 |
| Number (95% Confidence Interval) [percentage of participants] |
100.00
10000%
|
75.00
1875%
|
0.0
0%
|
40.0
800%
|
| Title | Overall Response Rate (ORR) Per Investigator Assessment |
|---|---|
| Description | 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 Frame | Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 1 | 4 | 12 | 5 |
| Number (95% Confidence Interval) [percentage of participants] |
100.0
10000%
|
75.0
1875%
|
0.0
0%
|
0.0
0%
|
| Title | Duration of Response (DOR) Per Investigator Assessment |
|---|---|
| Description | 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 Frame | Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastomia (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 1 | 3 | 12 | 5 |
| Median (95% Confidence Interval) [weeks] |
NA
|
NA
|
NA
|
NA
|
| Title | Time to Response (TTR) Per Investigator Assessment |
|---|---|
| Description | TTR is defined as the time from date of the first dose to date of first documented response (CR or PR) |
| Time Frame | Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 1 | 4 | 12 | 5 |
| Median (95% Confidence Interval) [weeks] |
7.1
|
16.4
|
NA
|
NA
|
| Title | Progression Free Survival (PFS) Per Investigator Assessments |
|---|---|
| Description | 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 Frame | Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| no participants met definition of PFS |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 0 | 2 | 9 | 5 |
| Median (95% Confidence Interval) [weeks] |
NA
|
1.7
|
1.7
|
| Title | Percent of Participant Deaths During Treatment and Follow-up |
|---|---|
| Description | Deaths due to any cause during treatment and 30 day follow-up |
| Time Frame | Baseline up to approximately 84 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were no deaths in the ALCL and IMT arms |
| Arm/Group Title | Anaplastic Large Cell Lymphoma (ALCL) | Inflammatory Myofibroblastic Tumor (IMT) | Glioblastoma (GBM) | Any Other ALK-positive Tumor |
|---|---|---|---|---|
| Arm/Group Description | Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive | Patients diagnosed with IMT with a confirmed translocation involving the ALK gene | Patients with GBM with a translocation involving the ALK gene | Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2). |
| Measure Participants | 1 | 4 | 12 | 5 |
| Number [percent of participants] |
0.0
0%
|
0.0
0%
|
25.0
208.3%
|
20.0
400%
|
Adverse Events
| Time Frame | 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Any sign or symptom that occured during the study treatment plus 30 days post treatment | |||||||||
| Arm/Group Title | Anaplastic Large Cell Lymphoma | Inflammatory Myofibroblastic Tumor | Glioblastoma | Any Other ALK+ Tumor | All Subjects | |||||
| Arm/Group Description | Anaplastic Large Cell Lymphoma | Inflammatory Myofibroblastic Tumor | Glioblastoma | Any other ALK+ tumor | All Subjects | |||||
All Cause Mortality |
||||||||||
| Anaplastic Large Cell Lymphoma | Inflammatory Myofibroblastic Tumor | Glioblastoma | Any Other ALK+ Tumor | All Subjects | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/4 (0%) | 3/12 (25%) | 1/5 (20%) | 4/22 (18.2%) | |||||
Serious Adverse Events |
||||||||||
| Anaplastic Large Cell Lymphoma | Inflammatory Myofibroblastic Tumor | Glioblastoma | Any Other ALK+ Tumor | All Subjects | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 2/4 (50%) | 10/12 (83.3%) | 4/5 (80%) | 16/22 (72.7%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Thrombocytopenia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 2/5 (40%) | 2/22 (9.1%) | |||||
| Gastrointestinal disorders | ||||||||||
| Stomatitis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Oedema peripheral | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Pyrexia | 0/1 (0%) | 1/4 (25%) | 1/12 (8.3%) | 2/5 (40%) | 4/22 (18.2%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Lung infection | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Pneumonia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Pyelonephritis | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Tooth infection | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Head injury | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Investigations | ||||||||||
| Haemoglobin decreased | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Transaminases increased | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Hypercalcaemia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Hyperglycaemia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Hypoalbuminaemia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Hyponatraemia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| Cerebrovascular accident | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Depressed level of consciousness | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Haemorrhage intracranial | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Hydrocephalus | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Hypersomnia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Intracranial pressure increased | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Paraesthesia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Seizure | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Nephrotic syndrome | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Renal failure | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis allergic | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Dermatitis bullous | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Paraneoplastic pemphigus | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Vascular disorders | ||||||||||
| Embolism | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Anaplastic Large Cell Lymphoma | Inflammatory Myofibroblastic Tumor | Glioblastoma | Any Other ALK+ Tumor | All Subjects | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 4/4 (100%) | 12/12 (100%) | 5/5 (100%) | 22/22 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/1 (0%) | 2/4 (50%) | 0/12 (0%) | 3/5 (60%) | 5/22 (22.7%) | |||||
| Leukocytosis | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Lymphopenia | 0/1 (0%) | 2/4 (50%) | 1/12 (8.3%) | 0/5 (0%) | 3/22 (13.6%) | |||||
| Neutropenia | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Thrombocytopenia | 0/1 (0%) | 0/4 (0%) | 3/12 (25%) | 2/5 (40%) | 5/22 (22.7%) | |||||
| Cardiac disorders | ||||||||||
| Bradycardia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Sinus bradycardia | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Tachycardia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain | 1/1 (100%) | 2/4 (50%) | 0/12 (0%) | 2/5 (40%) | 5/22 (22.7%) | |||||
| Abdominal pain upper | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Constipation | 0/1 (0%) | 2/4 (50%) | 2/12 (16.7%) | 0/5 (0%) | 4/22 (18.2%) | |||||
| Diarrhoea | 1/1 (100%) | 3/4 (75%) | 7/12 (58.3%) | 2/5 (40%) | 13/22 (59.1%) | |||||
| Eructation | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Flatulence | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Gastrooesophageal reflux disease | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Nausea | 1/1 (100%) | 3/4 (75%) | 6/12 (50%) | 3/5 (60%) | 13/22 (59.1%) | |||||
| Stomatitis | 0/1 (0%) | 1/4 (25%) | 2/12 (16.7%) | 0/5 (0%) | 3/22 (13.6%) | |||||
| Vomiting | 1/1 (100%) | 2/4 (50%) | 4/12 (33.3%) | 4/5 (80%) | 11/22 (50%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 4/5 (80%) | 5/22 (22.7%) | |||||
| Fatigue | 0/1 (0%) | 1/4 (25%) | 5/12 (41.7%) | 0/5 (0%) | 6/22 (27.3%) | |||||
| Gait disturbance | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Oedema | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Oedema peripheral | 0/1 (0%) | 0/4 (0%) | 3/12 (25%) | 0/5 (0%) | 3/22 (13.6%) | |||||
| Pain | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Infections and infestations | ||||||||||
| Bronchitis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Candiduria | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Catheter site cellulitis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Genital herpes | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Influenza | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Paronychia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Pyelonephritis | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Urinary tract infection | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Uterine infection | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Cartilage injury | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 1/1 (100%) | 3/4 (75%) | 2/12 (16.7%) | 1/5 (20%) | 7/22 (31.8%) | |||||
| Amylase increased | 0/1 (0%) | 2/4 (50%) | 0/12 (0%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Aspartate aminotransferase increased | 1/1 (100%) | 3/4 (75%) | 0/12 (0%) | 1/5 (20%) | 5/22 (22.7%) | |||||
| Blood alkaline phosphatase increased | 1/1 (100%) | 2/4 (50%) | 0/12 (0%) | 1/5 (20%) | 4/22 (18.2%) | |||||
| Blood bilirubin abnormal | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Blood bilirubin increased | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Blood creatinine increased | 0/1 (0%) | 2/4 (50%) | 0/12 (0%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Creatinine renal clearance increased | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Gamma-glutamyltransferase increased | 1/1 (100%) | 2/4 (50%) | 0/12 (0%) | 1/5 (20%) | 4/22 (18.2%) | |||||
| Lipase increased | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Weight decreased | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 0/1 (0%) | 2/4 (50%) | 0/12 (0%) | 1/5 (20%) | 3/22 (13.6%) | |||||
| Dehydration | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Hypercalcaemia | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Hyperglycaemia | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Hyperkalaemia | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Hypernatraemia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Hyperuricaemia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Hypokalaemia | 0/1 (0%) | 2/4 (50%) | 0/12 (0%) | 1/5 (20%) | 3/22 (13.6%) | |||||
| Hypomagnesaemia | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Increased appetite | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Back pain | 0/1 (0%) | 0/4 (0%) | 3/12 (25%) | 0/5 (0%) | 3/22 (13.6%) | |||||
| Muscular weakness | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Musculoskeletal pain | 0/1 (0%) | 0/4 (0%) | 0/12 (0%) | 1/5 (20%) | 1/22 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| Aphasia | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Cognitive disorder | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Depressed level of consciousness | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Dizziness | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Headache | 0/1 (0%) | 0/4 (0%) | 3/12 (25%) | 0/5 (0%) | 3/22 (13.6%) | |||||
| Hemiparesis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Somnolence | 0/1 (0%) | 0/4 (0%) | 2/12 (16.7%) | 0/5 (0%) | 2/22 (9.1%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 1/5 (20%) | 2/22 (9.1%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Renal failure | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Dyspnoea | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Epistaxis | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Lung disorder | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Respiratory disorder | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis acneiform | 0/1 (0%) | 0/4 (0%) | 1/12 (8.3%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Dermatitis bullous | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Palmar-plantar erythrodysaesthesia syndrome | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Photosensitivity reaction | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Pruritus | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
| Rash | 1/1 (100%) | 1/4 (25%) | 0/12 (0%) | 1/5 (20%) | 3/22 (13.6%) | |||||
| Skin toxicity | 0/1 (0%) | 1/4 (25%) | 0/12 (0%) | 0/5 (0%) | 1/22 (4.5%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 888-669-6682 |
| Novartis.email@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02465528
Other Study ID Numbers:
- CLDK378A2407
First Posted:
Jun 8, 2015
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019