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CompletedNCT00871663Updated Apr 20, 2015

Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)

A Phase 1 interventional study of SCH 727965 in Solid Tumors, Lymphoma, Non-Hodgkin and Multiple Myeloma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-20.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
123
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.

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Conditions studied

  • Solid Tumors
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Leukemia, Lymphocytic, Chronic. B-Cell
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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 123 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.

Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >=18 years, either sex, any race.
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  • There must be no known standard therapy, or disease must be refractory to standard therapy
  • Adequate hematologic, renal, and hepatic organ function and laboratory parameters
  • For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:

    • Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
    • Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.
  • Subjects with multiple myeloma must have measurable disease defined as:

    • Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
    • Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:

      • serum free light chain ratio greater than 5 times the normal ratio limit; and/or
      • measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
      • bone marrow involvement greater than 30%.
  • For B-cell chronic lymphocytic leukemia (B-CLL):

    • Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
    • Disease must be evaluable according to NCI-WG response criteria.

Exclusion criteria

Exclusion Criteria:

  • Symptomatic brain metastases or primary central nervous system malignancy.
  • Previous radiation therapy to >25% of the total bone marrow.
  • Previous treatment with SCH 727965.
  • Known HIV infection.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Advanced solid tumors

    Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts

    Drug: SCH 727965

  • Experimental
    Non-Hodgkin's lymphoma and multiple myeloma

    Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965

    Drug: SCH 727965

  • Experimental
    B cell chronic lymphocytic leukemia

    Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts

    Drug: SCH 727965

Interventions

  • DrugSCH 727965

    Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.

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What researchers measure

Primary outcomes

  1. Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.

    Time frame: End of trial

  2. In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.

    Time frame: End of trial

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Flynn J, Jones J, Johnson AJ, Andritsos L, Maddocks K, Jaglowski S, Hessler J, Grever MR, Im E, Zhou H, Zhu Y, Zhang D, Small K, Bannerji R, Byrd JC. Dinaciclib is a novel cyclin-dependent kinase inhibitor with significant clinical activity in relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2015 Jul;29(7):1524-9. doi: 10.1038/leu.2015.31. Epub 2015 Feb 24. PubMed 25708835 ↗
  • Nemunaitis JJ, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou YM, Statkevich P, Yao SL, Bannerji R. A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies. J Transl Med. 2013 Oct 16;11:259. doi: 10.1186/1479-5876-11-259. PubMed 24131779 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00871663
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 30, 2009
Start date
Aug 2006
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Apr 20, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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