A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Small Cell Lung Carcinoma

In brief

The purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (SCLC) subjects.

Key facts

Study ID

NCT01357395

Run by

Astex Pharmaceuticals, Inc.

People needed

23

Starts

2011-05-01

Expected to finish

2012-05-28

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC
• Measurable SCLC per RECIST guideline that meets one of the following:
• Disease progression by RECIST at anytime during platinum-etoposide (PE) chemotherapy;
• Relapse by RECIST within 90 days after completing PE chemotherapy;
• Stable disease by RECIST as best response after at least two (2) ≥ 21-day cycles of PE chemotherapy. The assessment of stable disease should be made at least 2 weeks after the start of the second cycle
• Subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria
• Start treatment with the same last regimen (dose and schedule) of first-line PE chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry
• ECOG performance status 0 to 2
• Adequate organ function
• Subjects with screening 12-lead ECG with measurable QTc interval of < 450 msec. If QTc ≥ 450 msec, then confirm the reading by evaluating the mean QTc interval of triplicate ECGs.
• Sign approved informed consent form

You may not qualify if…

• Prior exposure to amuvatinib
• No longer eligible for first-line PE chemotherapy due to toxicity and the Investigator believes that the risk of retreating with the same PE chemotherapy regimen would outweigh the benefit
• Ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the Investigator, is stable and does not compromise the safety of the subject
• Mixed SCLC and non-small cell lung cancer, or large cell lung cancer
• Untreated, unstable, or symptomatic brain metastasis
• Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial
• A life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or interfere with study outcomes

Where it is running

• University of Colorado Cancer Center — Aurora, Colorado, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• James Graham Brown Cancer Center, University of Louisville — Louisville, Kentucky, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Associates in Oncology and Hematology — Chattanooga, Tennessee, United States
• Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Wojewódzki Szpital Specjalistyczny — Radom, Masovian Voivodeship, Poland
• Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie — Warsaw, Masovian Voivodeship, Poland
• Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii — Przemyśl, Podkarpackie Voivodeship, Poland
• Wojewódzkie Centrum Onkologii — Gdansk, Pomeranian Voivodeship, Poland
• Specjalistyczny Szpital im. Alfreda Sokolowskiego — Szczecin, West Pomeranian Voivodeship, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.