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A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Study of CGC-11047 in Subjects With Advanced Refractory Solid Tumors


This is an open-label phase I, dose-escalation safety study in subjects with refractory
solid tumors. The primary objectives of the study are to assess the safety, tolerability,
and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous
infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is
2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to
receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor
response will be performed every 2 cycles.


Inclusion Criteria:



- non-hematological malignancy where standard therapeutic measures do not exist or no
longer effective.

- ECOG - 0-2.

- Life expectancy > 3 months.

Exclusion Criteria:

- chemotherapy or radiotherapy within 4 weeks prior to entering the study.

- previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell
transplantation.

- primary brain tumors or active brain metastases

- history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction
or evidence of a current significant ventricular conduction abnormality

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.

Outcome Time Frame:

The MTD had to occur during cycle 1 of treatment

Safety Issue:

Yes

Principal Investigator

Mark Ratain, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

47-01-001

NCT ID:

NCT00705653

Start Date:

March 2005

Completion Date:

August 2009

Related Keywords:

  • Cancer
  • cancer
  • advanced cancer
  • solid tumors
  • CGC-11047
  • PG-11047

Name

Location

University of Chicago, Cancer Research CentreChicago, Illinois  60637