Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bosutinib
SKI-606 · 10 trials · 6 indications
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.
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT.
Cytogenetic response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.
PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Advanced breast cancer | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | Clinical Tablet |
| 3 | ACTIVE_COMPARATOR | Moxifloxacin |
| 4 | EXPERIMENTAL | SKI-606 plus ketoconazole |
| 5 | PLACEBO_COMPARATOR | Placebo plus ketoconazole |
| SKI-606 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SKI-606 (Bosutinib) | DRUG | Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2. SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing. |
| SKI-606 | DRUG | - |
| Placebo | DRUG | - |
| Moxifloxacin | DRUG | - |
Inclusion Criteria: * Cytogenetic or Polymerase Chain Reaction based diagnosis of Chronic phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia: (Part 1), any phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Part 2), whose disease is resistant/refractory to ...
SKI-606, also known as bosutinib, is an investigational small molecule being studied for use in breast neoplasms, chronic myelogenous leukemia, solid tumors, and in healthy subjects. It is in clinical development for these oncology indications, though it is not approved for any of them.
SKI-606 is a kinase inhibitor, belonging to the -tinib class of drugs. It is designed to inhibit kinase activity, which plays a role in cancer cell growth and survival. Its development focuses on treating cancers such as breast cancer and chronic myelogenous leukemia.
SKI-606 is being developed by Pfizer, Inc., a biopharmaceutical company. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications, including breast cancer and chronic myelogenous leukemia.
SKI-606 has been studied in Phase 1 and Phase 2 clinical trials. These trials have been completed, and the drug remains investigational. It has not received FDA approval, and its development status is not currently reported as active in ongoing trials.
SKI-606 has been evaluated in several completed clinical trials. These include NCT00319254, a Phase 2 study in subjects with breast cancer; NCT00811070, a Phase 2 study in Japanese subjects with Philadelphia chromosome positive leukemias; NCT01001936, a Phase 1 study in subjects with solid tumors; and NCT01080365, a Phase 1 study comparing tablet formulations in healthy subjects.
Yes, SKI-606 is also known as bosutinib. Both names refer to the same investigational drug being developed by Pfizer. Clinical trials and literature may use either name to describe the compound.