A Safety Study in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01284335
First received: January 19, 2011
Last updated: September 16, 2013
Last verified: September 2013

January 19, 2011
September 16, 2013
July 2008
October 2012   (final data collection date for primary outcome measure)
Recommended Phase 2 dose [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01284335 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic, concentration maximum (Cmax) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]
  • Number of patients with a tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Number of participants with a clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic, area under the curve (AUC) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]
  • Pharmacokinetic, concentration maximum(Cmax) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]
  • Number of patients with a tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Number of participants with a clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic, area under the curve (AUC) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety Study in Patients With Advanced Solid Tumors
A Phase 1 Multicenter, Dose-escalation Study of LY573636-Sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors

The purpose of this study is to determine a safe dose of LY573636-sodium when used in 5 separate combinations with an approved cancer medication for treating patients 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-sodium combination treatments.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: Gemcitabine
    1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
    Other Names:
    • Gemzar
    • LY18011
  • Drug: Docetaxel
    60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
    Other Name: Taxotere
  • Drug: Temozolomide
    200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
    Other Name: Temodar
  • Drug: Cisplatin
    75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
    Other Names:
    • Platinol-AQ
    • Platinol
  • Drug: Erlotinib
    150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
    Other Name: Tarceva
  • Drug: LY573636
    Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
  • Experimental: Gemcitabine plus LY573636
    Interventions:
    • Drug: Gemcitabine
    • Drug: LY573636
  • Experimental: Docetaxel plus LY573636
    Interventions:
    • Drug: Docetaxel
    • Drug: LY573636
  • Experimental: Temozolomide plus LY573636
    Interventions:
    • Drug: Temozolomide
    • Drug: LY573636
  • Experimental: Cisplatin plus LY573636
    Interventions:
    • Drug: Cisplatin
    • Drug: LY573636
  • Experimental: Erlotinib plus LY573636
    Interventions:
    • Drug: Erlotinib
    • Drug: LY573636
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
December 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients 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. Patients 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
  • Patients with active central nervous system or brain metastasis at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis. Patients with stable CNS metastasis not requiring steroids may be eligible.
  • Have a current hematologic malignancy (other than lymphoma)
  • Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study)
  • Patients actively receiving warfarin (Coumadin®) therapy
  • Patients who have previously completed or withdrawn from any study investigating LY573636
  • Patients 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
  • Patients receiving amiodarone, quinidine, propofol, or clozapine.
  • Patients 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284335
12267, H8K-MC-JZAK
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP