Have you or your loved ones been diagnosed with advanced solid tumors?

You may be eligible to participate in a advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with advanced solid tumors? You may be eligible to participate in a advanced solid tumors clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Advanced Solid Tumors Clinical Trial

NCT00999401 | Phase 1 | Interventional

Have you or your loved ones been diagnosed with advanced solid tumors?

You may be eligible to participate in a advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with advanced solid tumors? You may be eligible to participate in a advanced solid tumors clinical trial.

Completed

Male & Female

18 Years +

This study has recruited 103 Participants

A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

A study of sequential administration of oral sapacitabine and oral Seliciclib in patients <br /> with advanced solid tumors.

Detailed Description

The primary objective of this study is to determine the maximum tolerated dose (MTD) or
recommended phase II doses of sapacitabine and seliciclib administered sequentially or
concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential
or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin
and peripheral blood mononuclear cells.

Treatments and/or Procedures

Sapacitabine and seliciclib

sequential or concomitant administration of sapacitabine and seliciclib

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

maximum tolerated dose

MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients

1-3 months

Secondary

tumor response rate

Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.

1-3 months

Secondary

pharmacodynamic effects in skin and peripheral mononuclear cells

PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.

1-3 months

Study Criteria

Inclusion Criteria:

  -  Incurable advanced solid tumors that are no longer responding to conventional therapy
     or for which no effective therapy exists; at the RD of Part 1, an extension cohort up
     to 20 patients with metastatic breast cancer who are known to be BRCA mutation
     carriers will be enrolled.

  -  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