Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

Browse trials for

• Preleukemia 1,317
• Myelodysplastic Syndromes 2,124
• Myeloproliferative Disorders 626
• Myelodysplastic-Myeloproliferative Diseases 231
• Syndrome 9,217

Keywords

• refractory anemia with excess blasts
• refractory anemia with ringed sideroblasts
• refractory cytopenia with multilineage dysplasia
• chronic myelomonocytic leukemia
• de novo myelodysplastic syndromes
• secondary myelodysplastic syndromes
• myelodysplastic/myeloproliferative neoplasm, unclassifiable
• refractory anemia
• previously treated myelodysplastic syndromes

Preleukemia

1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.

This study's enrollment of 155 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Vatalanib

  Adult patients with MDS receive treatment with vatalanib.

  Drug: vatalanib

Interventions

• Drugvatalanib

  Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

  Also known as: PTK787/ZK 222584

Primary outcomes

1. Number of Participants With Response

   Response was measured by International Standardized Response Criteria for MDS * Complete Response: Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines; Hgb \> 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia * Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant. Hematologic improvement: * Erythroid (HI-E): For participants with baseline HGB \< 11g/dL, Major: \> 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements * Platelet (HI-P): For participants with baseline PLT \< 100 K/L: Major: absolute increase of \> 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of \>10 K/L) * Neutrophil (HI-N): For participants with baseline ANC \< 1.5 K/L, Major: \> 100% increase (net increase \> 0.5 K/L). Minor: \> 100% increase (absolute increase \< 0.5 K/L)

   Time frame: Duration of study (up to 5 years)

2. Time to Transformation to AML

   Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.

   Time frame: Duration of study (up to 5 years)

Secondary outcomes

1. Duration of Response

   Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method. Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure).

   Time frame: 5 yrs

2. Overall Survival

   Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.

   Time frame: Duration of study (up to 5 years)

3. Progression-free Survival

   Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method. Progression is defined as * For patients with \<5% bone marrow blasts: ≥50% increase in blasts to \>5% blasts * For patients with 5-10% bone marrow blasts: ≥50% increase to \>10% blasts * For patients with 10-19% bone marrow blasts: increase to ≥20% blasts * One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC \< 1.5 K/L or PLT\< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent Progression after HI: Includes one or more of the following * Decrement of 50% or greater from maximum response levels in ANC \< 1.5 K/L or PLT \< 100 K/L * Reduction in HGB concentration by at least 2 g/dL * Becoming transfusion dependent

   Time frame: Duration of study (up to 5 years)

Baseline characteristics

Publications

• Gupta P, Miller AA, Owzar K, et al.: Pharmacokinetics of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] J Clin Oncol 24 (Suppl 18): A-6573, 355s, 2006.
• Gupta P, Sanford BL, Yu D, et al.: A phase II study of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] Blood 108 (11): A-2665, 2006.