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A Phase 2, Open-Label, Multi-Center Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer Subjects Who Have Not Responded to Standard Treatment or Relapsed After Standard Treatment


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Carcinoma

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Trial Information

A Phase 2, Open-Label, Multi-Center Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer Subjects Who Have Not Responded to Standard Treatment or Relapsed After Standard Treatment


Amuvatinib is an oral multi-targeted tyrosine kinase inhibitor which inhibits the mutant
forms of c-Kit and PDGFR alpha. It also disrupts DNA repair likely through suppression of
Homologous Recombination protein Rad51. In a Phase 1b clinical study in combination with
VP-16 and carboplatin, responses in SCLC were observed. In vitro and in vivo data
demonstrated amuvatinib synergy with VP-16 thereby further supporting this combination for
continued evaluation in clinical trials. Pharmacokinetic data from Phase 1 clinical trials
suggest that co-administration of amuvatinib did not alter exposures of standard of care
agents VP-16 or carboplatin as measured by overall exposure.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall objective response rate (CR or PR)

Outcome Time Frame:

3 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SGI-0470-07

NCT ID:

NCT01357395

Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Associates in Oncology and HematologyChattanooga, Tennessee  37404
James Graham Brown Cancer Center, University of LouisvilleLouisville, Kentucky  40202
Vanderbilt - Ingram Cancer CenterNashville, Tennessee  37232