Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT01357395
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC
2. 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
3. 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
4. ECOG performance status 0 to 2
5. Adequate organ function
6. 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.
7. Sign approved informed consent form
Exclusion Criteria:
1. Prior exposure to amuvatinib
2. 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
3. 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
4. Mixed SCLC and non-small cell lung cancer, or large cell lung cancer
5. Untreated, unstable, or symptomatic brain metastasis
6. Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial
7. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01357395
Study Brief:
Protocol Section:
NCT01357395