Trial · NCT04744532
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 part: Dose-limiting toxicity (DLT) | During the first 4 weeks of treatment with bosutinib | Dose limiting toxity (DLT) for 4 weeks after initiating bosutinib |
| Primary | Phase 1 part: Dose-limiting toxicity (DLT) | Up to 12 weeks of treatment with bosutinib | Dose limiting toxity (DLT) during all treatment period (12 weeks) |
| Primary | Phase 2 part: Change in ALSFRS-R from baseline to week 24 in each 200mg and 300mg group compared with the external published data of placebo group | Up to 24 weeks of treatment with bosutinib | Change from baseline in ALSFRS-R at week 24 in each 200mg and 300mg group will be compared with the external published data of placebo group excluded bulbar-onset type in edaravone study (MCI186-19) |
| Primary | Phase 2 part: Adverse events | Up to 24 weeks of treatment with bosutinib | Safety in each dose group and pooled dose group during 24 weeks of treatment. Adverse events will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.4.03). |
| Primary | Phase 2 part: Incidence of abnormal laboratory test results | Up to 24 weeks of treatment with bosutinib | Hematology, Blood chemistry, Coagulation test, etc. |
| Primary | Phase 2 part: Incidence of abnormal vital signs | Up to 24 weeks of treatment with bosutinib | Blood pressure, Pulse rate, Body temperature |
| Primary | Phase 2 part: Incidence of abnormal ECG recordings | Up to 24 weeks of treatment with bosutinib | ECG; electrocardiogram |
| Primary | Phase 2 part: Incidence of abnormal X-ray findings | Up to 24 weeks of treatment with bosutinib | chest X-ray examination |
| Secondary | Phase 1 part: Adverse events | Up to 12 weeks of treatment with bosutinib | Adverse events are graded based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4.03. |
| Secondary | Phase 1 part: Incidence of abnormal laboratory test results | Up to 12 weeks of treatment with bosutinib | Hematology, Blood chemistry, Coagulation test, etc. |
| Secondary | Phase 1 part: Incidence of abnormal vital signs | Up to 12 weeks of treatment with bosutinib | Blood pressure, Pulse rate, Body temperature |
| Secondary | Phase 1 part: Incidence of abnormal ECG recordings | Up to 12 weeks of treatment with bosutinib | ECG; electrocardiogram |
| Secondary | Phase 1 part: Incidence of abnormal X-ray findings | Up to 12 weeks of treatment with bosutinib | chest X-ray examination |
| Secondary | Phase 2 part: Change in ALSFRS-R from baseline to week 24 in combined group of 200 mg and 300 mg group compared with placebo group | Up to 24 weeks of treatment with bosutinib | Change from baseline in ALSFRS-R at week 24 in combined group of 200 mg and 300 mg group will be compared with the external published data of placebo group excluded bulbar-onset type in edaravone study (MCI186-19) |
| Secondary | Phase 2 part: Change in ALSFRS-R from baseline to week 24 in combined group of 200 mg and 300 mg group compared with edaravone group | Up to 24 weeks of treatment with bosutinib | Change from baseline in ALSFRS-R at week 24 in combined group of 200 mg and 300 mg group will be compared with the external published data of edaravone group excluded bulbar-onset type in edaravone study (MCI186-19) |
| Other | Phase 1 part: Change in total ALSFRS-R score | Up to 12 weeks of treatment with bosutinib | ALSFRS-R score; ALS Functional Rating Scale-Revised score, the maximum points 48, the minimum points 0, higher scores mean a better outcome. |
| Other | Phase 1 part: Change in the Japan ALS severity classification | Up to 12 weeks of treatment with bosutinib | Grade 1 to Grade 5, lower grade means a better outcome. |
| Other | Phase 1 part: Change in %FVC | Up to 12 weeks of treatment with bosutinib | FVC; Forced Vital Capacity Changes from baseline in %FVC |
| Other | Phase 1 part: Change in grip power | Up to 12 weeks of treatment with bosutinib | Changes from baseline in grip strength |
| Other | Phase 1 part: Change in blood neurofilament L | Up to 12 weeks of treatment with bosutinib | Change in plasma neurofilament L during the observation period and the study treatment period |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04744532/registered