A Safety Study in Participants With Advanced Solid Tumors

Lilly

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Temozolomide; Drug: Gemcitabine; Drug: Docetaxel; Drug: Erlotinib; Drug: Cisplatin; Drug: LY573636

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284335

12267

H8K-MC-JZAK (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5 separate combinations with an approved cancer medication for treating participants with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associated with the LY573636 combination treatments.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have histologically confirmed solid malignancy or lymphoma that is unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel, temozolomide, cisplatin, or erlotinib would otherwise be appropriate
• Must have tumor progression after receiving standard/approved chemotherapy or limited treatment options
• Must have measurable or nonmeasurable disease
• Have given written informed consent prior to any study-specific procedures
• Must have adequate hepatic, hematologic and renal function
• Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. Endocrine therapies for the treatment of prostate cancer may be continued, at the discretion of the investigator. Whole brain radiation must have been completed 90 days before starting study therapy. Participants without evidence of brain metastases who have received prophylactic whole brain irradiation as part of standard of care for small cell lung cancer may be included in the study with a shorter washout period pending approval by the Lilly physician.
• Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.
• Females with child-bearing potential must have had a negative serum pregnancy test within 7 days prior to the first dose of study drug.
• Must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L).
• Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion criteria

• Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
• Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in the study
• Participants with active central nervous system or brain metastasis at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis. Participants with stable CNS metastasis not requiring steroids may be eligible.
• Have a current hematologic malignancy (other than lymphoma)
• Participants with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study)
• Participants actively receiving warfarin (Coumadin®) therapy
• Participants who have previously completed or withdrawn from any study investigating LY573636
• Participants with a known hypersensitivity to one of the combination drugs cannot be enrolled to the treatment arm which includes that chemotherapeutic combination
• Females who are pregnant or breast feeding
• Have known positive test results of HIV, hepatitis B, or hepatitis C
• Participants receiving amiodarone, quinidine, propofol, or clozapine.
• Participants receiving treatment with strong or moderate inhibitors of CYP2C19, including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if not administered 72 hours before or after LY573636 administration.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

234 participants in 5 patient groups

Gemcitabine plus LY573636

Experimental group

Treatment:

Drug: LY573636

Drug: Gemcitabine

Docetaxel plus LY573636

Experimental group

Treatment:

Drug: Docetaxel

Drug: LY573636

Temozolomide plus LY573636

Experimental group

Treatment:

Drug: LY573636

Drug: Temozolomide

Cisplatin plus LY573636

Experimental group

Treatment:

Drug: LY573636

Drug: Cisplatin

Erlotinib plus LY573636

Experimental group

Treatment:

Drug: LY573636

Drug: Erlotinib