Last reviewed · How we verify

NCT00871910

Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

Completed Phase 1 Last updated 23 October 2017
What this trial tests

Phase 1 trial testing SCH 727965 in Solid Tumors in 81 participants. Completed in 22 February 2010.

Timeline
11 October 2006
Primary endpoint
22 February 2010
22 February 2010

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment81
Start date11 October 2006
Primary completion22 February 2010
Estimated completion22 February 2010

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Solid Tumors or Lymphoma, Non-Hodgkin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies.
    Mita MM, Mita AC, Moseley JL, Poon J, et al · · 2017 · cited 46× · PMID 28859059 · DOI 10.1038/bjc.2017.288
  2. CDK9 inhibitors in multiple myeloma: a review of progress and perspectives.
    Borowczak J, Szczerbowski K, Ahmadi N, Szylberg Ł. · · 2022 · cited 23× · PMID 35092513 · DOI 10.1007/s12032-021-01636-1
  3. Enhancers in T Cell development and malignant lesions.
    Zhang T, Zou L. · · 2024 · PMID 39284807 · DOI 10.1038/s41420-024-02160-7

Verify or expand the search:

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00871910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing