Trial · NCT00261846
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
NCT00261846, Phase 2, Completed, Pfizer; results first posted 2013-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias. Trials, record NCT00261846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00261846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
- NCT number
- NCT00261846
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 571 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Bosutinib
- First posted
- 2005-12-05
- Last updated
- 2017-07-27
- Other registries' IDs
- eudract:2005-004230-40
- Results first posted
- 2013-03-12
- Limitations and caveats
- Analyses of progression free survival and overall survival was based on all-treated population, instead of evaluable population which was the primary efficacy population as per planned analyses.
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) | Part 1 Baseline up to Day 28 | DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). |
| Primary | Maximum Tolerated Dose (MTD) | Part 1 Baseline up to Day 28 | MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable. |
| Primary | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | |
| Primary | Plasma Decay Half-Life (t1/2) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NA = not estimable. |
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48). |
| Primary | Area Under the Concentration-Time Curve (AUC) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. NA = not estimable. |
| Primary | Apparent Oral Clearance (CL/F) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. NA = not estimable. |
| Primary | Apparent Volume of Distribution (Vz/F) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
| Primary | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 | Maximum plasma concentration over 24 hours at steady state (ss), on Day 15. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) | Part 1 Baseline up to Day 28 | Safety population included all participants who received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) | Part 1 Baseline up to Day 28 | Safety population included all participants who received at least 1 dose of study medication | mg | NUMBER |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. | nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment. | hours (hrs) | MEDIAN |
| PRIMARY | Plasma Decay Half-Life (t1/2) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. | hrs | MEAN |
| PRIMARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. | ng*hr/mL | MEAN |
| PRIMARY | Area Under the Concentration-Time Curve (AUC) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. | ng*hr/mL | MEAN |
| PRIMARY | Apparent Oral Clearance (CL/F) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. | liter per hour (L/hr) | MEAN |
| PRIMARY | Apparent Volume of Distribution (Vz/F) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. | liter | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1 | 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 | Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. | ng/mL | MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group1,257
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | Bosutinib 400 mg (Part 1) | 0 | participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) | Bosutinib 500 mg (Part 1) | 0 | participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) | Bosutinib 600 mg (Part 1) | 1 | participants | ||
| Maximum Tolerated Dose (MTD) | Bosutinib 400 mg (Part 1) | NA | mg | ||
| Maximum Tolerated Dose (MTD) | Bosutinib 500 mg (Part 1) | NA | mg | ||
| Maximum Tolerated Dose (MTD) | Bosutinib 600 mg (Part 1) | NA | mg | ||
| Maximum Observed Plasma Concentration (Cmax) - Part 1 | Bosutinib 400 mg (Part 1) | 89.3 | Standard Deviation 50.0 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) - Part 1 | Bosutinib 500 mg (Part 1) | 101.0 | Standard Deviation 35.6 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) - Part 1 | Bosutinib 600 mg (Part 1) | 120.0 | Standard Deviation 40.2 | nanogram per milliliter (ng/mL) | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | Bosutinib 400 mg (Part 1) | 4.00 | Full Range 3.33 to 48.08 | hours (hrs) |
1 to 10 of 1,257Source ClinicalTrials.gov
See all 1,257 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 400 mg (Part 1) | 3 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg (Part 1) | 3 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 600 mg (Part 1) | 12 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 0 | |
| Period 1: Part 1 (Dose Escalation) | STARTED | AP-CML Total (Part 2) | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events4,302
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 61 | 195 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 32 | 89 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 3 | 5 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 9 | 38 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 18 | 50 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 12 | 26 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | AP-CML Total (Part 2) | 35 | 79 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | BP-CML Total (Part 2) | 18 | 64 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib 500 mg, Ph+ ALL (Part 2) | 5 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 45 | 195 |
1 to 10 of 4,302Source ClinicalTrials.gov
See all 4,302 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | ||
| Total, all-cause mortality | AP-CML Total (Part 2) | ||
| Total, all-cause mortality | BP-CML Total (Part 2) | ||
| Total, all-cause mortality | Bosutinib 500 mg, Ph+ ALL (Part 2) | ||
| Total, other adverse events | Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 194 | 195 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00261846
GET https://conductscience.org/api/trials/v1/NCT00261846/registered?page=2