New York, New York 10021

  • Unspecified Adult Solid Tumor, Protocol Specific


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of LY293111 in treating patients who have advanced solid tumors.

Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose of LY293111 in patients with advanced solid tumors. II. Determine the safety profile and pharmacokinetics of this regimen in these patients. III. Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive oral LY293111 twice daily. Treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY293111 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed at 30 days. PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or metastatic solid tumor for which no curative therapy exists No hematologic malignancies Measurable or evaluable disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No concurrent systemic disorder that would preclude study No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No more than 3 prior chemotherapy regimens for metastatic disease At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy and recovered No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational therapy No other concurrent experimental medications

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

LY293111 in Treating Patients With Advanced Solid Tumors

Official Title:

A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors (Protocol H6H-MC-JEAI)

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Gary K. Schwartz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:June 2000
Completion Date:February 2003
Completion Type:Actual
Primary Completion Date:February 2003
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 17, 2013
First Received Date:October 4, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: September 23, 2021

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