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A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

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Trial Information

A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Incurable advanced solid tumors that are no longer responding to conventional therapy
or for which no effective therapy exists

- Age 18 years or older

- ECOG 0-2

- Life expectancy ≥ 3 months

- Evaluable disease

- Adequate bone marrow function

- Adequate renal function

- Adequate liver function

- At least 3 weeks from prior systemic treatments including investigational anti-cancer
therapy, radiation therapy; and have recovered from prior toxicities

- Able to swallow capsules

- At least 3 weeks from major surgery

- Agree to practice effective contraception

- Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

- Previously untreated CNS metastases or progressive CNS metastases

- Currently receiving radiotherapy, biological therapy, or any other investigational
agents

- Uncontrolled intercurrent illness including

- Pregnant or lactating women

- Known to be HIV-positive

- A history of active hepatitis B and/or hepatitis C infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

1-3 months

Safety Issue:

Yes

Principal Investigator

Geoffrey Shapiro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CYC682-07

NCT ID:

NCT00999401

Start Date:

February 2009

Completion Date:

September 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Dana Farber Cancer InstituteBoston, Massachusetts  02115