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

NCT ID: NCT00871663

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-10-31

Brief 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.

Conditions

Solid Tumors; Lymphoma, Non-Hodgkin; Multiple Myeloma; Leukemia, Lymphocytic, Chronic. B-Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advanced solid tumors

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

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

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

Non-Hodgkin's lymphoma and multiple myeloma

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

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

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

B cell chronic lymphocytic leukemia

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

Group Type: EXPERIMENTAL

SCH 727965

Intervention Type: DRUG

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

Interventions

SCH 727965

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 25708835 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24131779 (View on PubMed)

Other Identifiers

P04629

Identifier Type: -

Identifier Source: org_study_id