NCT00052273

Brief Summary

RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

January 24, 2003

Last Update Submit

July 30, 2020

Conditions

AdultSolid Tumor

Keywords

unspecified adult solid tumorprotocol specific

Interventions

capecitabineDRUG
enzastaurin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • Measurable or evaluable disease
  • and over
  • ECOG 0-2
  • Hematopoietic
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed)
  • Hepatic
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Renal
  • Creatinine clearance at least 50 mL/min
  • Potassium at least 3.4 mEq/L
  • Calcium at least 8.4 mg/dL
  • +22 more criteria

You may not qualify if:

  • known untreated or symptomatic CNS metastases
  • concurrent hematologic malignancies
  • gastrointestinal disorder that would interfere with oral drug absorption
  • serious concurrent systemic disorder
  • compliance issues that would preclude study
  • geographical conditions that would preclude study
  • active infection
  • prior hypersensitivity to any component of study drugs
  • pregnant or nursing
  • concurrent immunotherapy
  • concurrent routine filgrastim (G-CSF)
  • other concurrent chemotherapy
  • other concurrent hormonal therapy
  • concurrent radiotherapy (including palliative therapy)
  • other concurrent experimental medications
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Carolyn Britten, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

December 1, 2002

Primary Completion

November 1, 2004

Study Completion

October 1, 2005

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(1)