E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects. |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034877 |
E.1.2 | Term | Philadelphia chromosome positive |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009012 |
E.1.2 | Term | Chronic myelogenous leukemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000845 |
E.1.2 | Term | Acute lymphoblastic leukemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to determine the long term safety and tolerability of dasatinib.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Signed Written Informed Consent
2) Target Population (consistent with prior CA180039 and START protocols)
a) Treatment on protocols CA180005, CA180006, CA180013, CA180015,
CA180017, or CA180039.
b) Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the
opinion of the Investigator.
3) Age and Sex
Men and women, ages 18 and older may participate.
Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least
1 month (4 weeks) before and at least 3 months (12 weeks) after the last dose of
investigational product in such a manner that risk of pregnancy is minimized. |
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E.4 | Principal exclusion criteria |
1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for at least one month (4 weeks) before
and for at least 3 months (12 weeks) after the last dose of study medication.
b) WOCBP using a prohibited contraceptive method (Not applicable for this study).
c) Women who are pregnant or breastfeeding
d) Women with a positive pregnancy test on enrollment or prior to investigational
product administration.
e) Sexually active fertile men whose sexual partner(s) are WOCBP, who are
unwilling or unable to use an effective method to avoid pregnancy for the entire
study period and for at least 3 months (12 weeks) after completion of study
medication.
2) Medical History and Concurrent Diseases
a) A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy
b) Dementia or altered mental status that would prohibit the understanding or
rendering of informed consent
3) Prohibited Treatments and/or Therapies
a) Subjects currently taking drugs that are generally accepted to have a risk of
causing Torsades de Pointes including, but not limited to:
* quinidine, procainamide, disopyramide
* amiodarone, sotalol, ibutilide, dofetilide
* erythromycins, clarithromycin
* chloropromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone
* cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
b) Subjects taking medications known to be potent CYP3A4 inhibitors
(i.e.ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz).
4) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness
Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety
In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation and nonserious AEs of special interest, which include: fluid retention, cardiac events, skin toxicity, hemorrhage, and myelosuppression will be collected. The exception will be in certain countries where all AEs are required to be collected and reported per local regulations. Adverse events will be graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Efficacy
Efficacy analysis will include major molecular response assessments. BCR-ABL transcripts in peripheral blood will be evaluated using real time quantitative polymerase chain reaction (RQ-PCR). Cytogenetic assessments are not required and will be performed at the Investigators' discretion - cytogenetic data will not be collected. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Efficacy/ Safety and tolerability data assessed every 6 months |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Finland |
Germany |
Hungary |
Ireland |
Italy |
Korea, Republic of |
Peru |
Poland |
Russian Federation |
Singapore |
South Africa |
Spain |
Switzerland |
Thailand |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 9 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |