A Phase I Dose Escalation of MK-0457 in Combination With Dasatinib in Patients With Refractory Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. - ND
- Conditions
- Patients with Refractory Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic.MedDRA version: 9.1Level: LLTClassification code 10009013Term: Chronic myeloid leukaemia
- Registration Number
- EUCTR2007-003674-26-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
1Patients must have chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
2Patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for CML or Ph+ ALL and be evaluable for hematologic response prior to entering the study.
3Patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry.
4Patient is male or female of any race, and ≥18 years of age on day of signing informed consent.
1Patient must have performance status ≤ 2 on the ECOG Performance Scale (Appendix 6.1).
6.Patients must have the following laboratory values unless considered due to leukemia: i) ALT and AST ≤ 2.5 x upper limit of normal (ULN) ii) Serum total bilirubin ≤ 2.0 x ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 2.0 ULN
iii) Serum creatinine ≤ 1.5 x ULN OR
≥ 60ml/min for patients with creatinine levels >1.5 X institutional ULN
2Female patient of childbearing potential has a negative serum or urine pregnancy test within 14 days of study enrollment.
3Patient, or the patient?s legal representative, has voluntarily agreed to participate by giving written informed consent.
4Patients with active CNS disease are included and may be treated concurrently with intrathecal therapy as per institutional standards.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1Patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. Pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility.
2 Patient has unresolved ≥ grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry.
3Patient has known hypersensitivity to the components of study drug or its analogs.
4Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient?s participation for the full duration of the study, or is not in the best interest of the patient to participate.
5Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
1Patient is, at the time of signing informed consent, a regular user (including ?recreational use?) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
2Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
3Patient has symptomatic ascites, pericardial or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
4Patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy.
5Patient has a LVEF <40% by multigated radionucleotide angiography (MUGA) or echocardiography.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method