CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
PF-04449913drug
Likely dose
PF-04449913 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01842646
NCT01842646Phase 2Completed
CompareCT.gov

A Phase II Study Evaluating the Oral Smoothened Inhibitor PF-04449913 in Patients With Myelodysplastic Syndrome (MDS)

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Apr 29, 2013·Updated Jun 14, 2021

In Brief

A Phase 2 clinical trial evaluating PF-04449913 for Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). Completed, enrolled 35 participants across 1 site.

Detailed Summary

This study is being done to see how safe an investigational drug is and test how well it will work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML)
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2013
Enrollment StartAug 29, 2013
Primary CompletionJan 31, 2016
Study CompletionJun 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.2 years ago

Interventions

PF-04449913drug

Patients will be enrolled according to a two-step study design. Twenty patients will be enrolled in the first stage. All patients will be given a daily oral dose of PF-0444913 100 mg for up to 4 cycles, with an optional continuation phase. Dose escalation to 200 mg will be provided for patients who do not have at least hematologic improvement following 2 cycles, and dose reduction to 50 mg will be permitted for patients with significant toxicity. If at least 2 patients respond in the initial stage, and additional 15 patients will be enrolled in the second stage.