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

• Status: Completed
• Trial end date: 2012-05-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Etoposide; Etoposide phosphate

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