NCT00052273

CompletedPhase 1

LY317615 Plus Capecitabine in Treating Patients With Advance...

Jonsson Comprehensive Cancer Center Source

Jonsson Comprehensive Cancer Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CDR0000258138

Secondary identifiers

UCLA-0206061

LILLY-H6Q-MC-JCAH

NCI-G02-2132

Study Type

interventional

Actual enrollment (reported)

16

Locations

1 country

Sites

1

Timeline

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2004

Actual (reported)

Study Completion

October 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: October 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 24, 2003
Actual (reported)
First Posted
January 27, 2003
Actual (reported)
Primary Completion
November 2004
Actual (reported)
Study Completion
October 2005
Actual (reported)

Last Updated: August 3, 2020
Status Verified: August 2012
Last Update Submitted: July 30, 2020

Conditions

Adult Solid Tumor

Keywords

unspecified adult solid tumorprotocol specific

Interventions

capecitabineDrug

enzastaurin hydrochlorideDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Jonsson Comprehensive Cancer Center
Otherlead
Eli Lilly and Company
Industrycollaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

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

Enrollment

16 participants (actual enrollment reported by the registry).

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Completed

NCT00253565

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Phase 1Completed

NCT00049244

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Phase 1Unknown

NCT00010023

Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1Completed

NCT00005839

Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor

Phase 1Completed

NCT00251407

Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

Phase 1Completed

NCT03364400

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

Phase 1Unknown

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.

Primary Completion

November 2004

Actual (reported)

Study Completion

October 2005

Actual (reported)

Last Updated

August 3, 2020

Record last verified: 2012-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00052273
Data provider: ClinicalTrials.gov
Source updated: 2020-08-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:27 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations