Know Cancer

or
forgot password

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic. B-Cell

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

End of trial

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P04629

NCT ID:

NCT00871663

Start Date:

August 2006

Completion Date:

October 2012

Related Keywords:

  • Solid Tumors
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Leukemia, Lymphocytic, Chronic. B-Cell
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location