A Safety Study in Participants With Advanced Solid Tumors

Conditions

• Advanced Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine — DRUG
  1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
• Docetaxel — DRUG
  60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
• Temozolomide — DRUG
  200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
• Cisplatin — DRUG
  75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
• Erlotinib — DRUG
  150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
• LY573636 — DRUG
  Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Study Details

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.

Key Dates

First listed

Jan 27, 2011

Start date

Jul 31, 2008

Status verified

Dec 2018

Primary completion

Oct 31, 2012

Completion

May 31, 2016

Study Design

Enrollment

234 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gemcitabine plus LY573636
• Experimental: Docetaxel plus LY573636
• Experimental: Temozolomide plus LY573636
• Experimental: Cisplatin plus LY573636
• Experimental: Erlotinib plus LY573636

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities Cycle 1 [ Time Frame: Baseline to Cycle 1 (Up to Day 28) ]

Locations (19)

Find similar trials in Birmingham, AL

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