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Hydrea (Hydroxyurea) - Summary

 
 



HYDREA SUMMARY

HYDREA (hydroxyurea capsules, USP) is an antineoplastic agent available for oral use as capsules providing 500 mg hydroxyurea.

HYDREA (hydroxyurea) is indicated for the following:

Significant tumor response to HYDREA (hydroxyurea capsules, USP) has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary.

Hydroxyurea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.


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NEWS HIGHLIGHTS

Media Articles Related to Hydrea (Hydroxyurea)

Early end to sickle cell anemia clinical trial prompted by successful outcome
Source: Blood / Hematology News From Medical News Today [2014.11.22]
Conclusive data show that hydroxyurea therapy offers safe and effective disease management of sickle cell anemia (SCA) and reduces the risk of stroke, prompting early termination by the National...

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Published Studies Related to Hydrea (Hydroxyurea)

Hydroxyurea and growth in young children with sickle cell disease. [2014]
Effects of hydroxyurea (HU) on growth in very young children are not known... CONCLUSIONS: Both groups had normal or near normal anthropometric measures during

Impact of hydroxyurea on clinical events in the BABY HUG trial. [2012]
The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups...

Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia. [2012]
CONCLUSION: Treatment with hydroxyurea for 24 months did not influence GFR in

Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial. [2012]
CONCLUSIONS: These data provide additional support to the safety profile of

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload. [2011.12.01]
BACKGROUND: Stroke occurs in 5-10% of children with sickle cell anemia (SCA) and has a high (>50%) risk of recurrence without therapy. Chronic monthly erythrocyte transfusions effectively prevent recurrent stroke, but their long-term use is limited by serious side effects, including iron overload. An alternative to transfusion for secondary stroke prevention in SCA is needed, especially one that also improves the management of iron overload... CONCLUSION: Investigation of alternative treatments in SWiTCH could lead to changes in the management of cerebrovascular disease for selected patients with SCA, stroke, and iron overload. Copyright (c) 2011 Wiley-Liss, Inc.

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Clinical Trials Related to Hydrea (Hydroxyurea)

Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent MG [Recruiting]
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on & not on EIAEDs when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among RMG pts including radiographic response rate, 6-month progression free survival rate & median PFS

Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera [Recruiting]
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Recruited patients will be randomly assigned to one of the following treatment groups:

- group A: 50 mg o. d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study;

- group B: 50 mg b. i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study.

The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.

In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.

After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:

- Partial or Complete Response at week 12:

- group A: continue 50 mg o. d.;

- group B: continue 50 mg b. i.d.;

- No Response at week 12:

- group A: increase to 50 mg b. i.d.;

- group B: increase to 50 mg t. i.d.. At any time during study course, if toxicity is

observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.

The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease [Recruiting]
In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent inflammatory state and abnormal RBC adhesion to the endothelium trigger these phenomenon. Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the clinical response does not correlate consistently with the degree and time of HbF increment, suggesting that HU clinical benefits may involve other mechanisms such as the induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.

Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea [Recruiting]
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.

Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE) [Recruiting]
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and

conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative

regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.

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Reports of Suspected Hydrea (Hydroxyurea) Side Effects

Pancytopenia (11)Renal Failure Acute (10)Dermatitis Bullous (8)Anaemia (7)Aplasia (7)Skin Ulcer (6)Thrombocytopenia (6)Haemorrhage (5)Drug Interaction (5)Platelet Count Increased (5)more >>


Page last updated: 2014-11-30

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