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Clinical Trial VICCTHN1244

Title

Phase 1, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-396 in Patients with Advanced Solid Tumors

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHN1244
  • Open Date: 07/25/2012
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the safety/tolerability of X-396 and determine the maximum tolerated dose (MTD) of X-396 as a single agent.
  • Disease Sites: Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: X-396
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01625234
  • Secondary Protocol No: X396-CLI-101

Description

This research study is being done to evaluate the safety of an investigational drug, X-396, and to determine the best dose to use for future studies.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy. Patients may have received prior crizotinib and/or second generation ALK TKIs.
2. Eastern Cooperative Group ECOG) Performance Status score of 0 or 1.
3. Ability to swallow and retain oral medication.
4. Adequate organ system function.
5. Patients with treated asymptomatic CNS metastases are eligible. ALK positive patients with untreated asymptomatic CNS lesions may be allowed to enroll.
6. Male patients willing to use adequate contraceptive measures.
7. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures.
8. Patients must be ≥ 18 years of age.
9. Patients must have measurable or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study (except for patients with CNS metastases).
10. Patients entering this study will be asked to provide tissue for correlative testing.
11. For the expanded cohort portion of the study, NSCLC patients with ALK genomic alterations.
12. Willingness and ability to comply with the trial and follow-up procedures.
13. Ability to understand the nature of this trial and give written informed consent.
Exclusion Criteria:
1. Patients currently receiving cancer therapy.
2. Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of X-396.
3. Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
4. Prior stem cell transplant.
5. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to X-396 (e.g., crizotinib) or to the active ingredient of X-396.
6. Patients with primary CNS tumors are ineligible.
7. Concomitant use of drugs with a risk of causing prolonged QTc and/or Torsades de Pointes.
8. Concomitant use of herbal medications at least 7 days prior to the first dose of study drug and throughout participation in the trial.
9. Females who are pregnant or breastfeeding.
10. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of X-396.
11. Clinically significant cardiovascular disease.
12. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
14. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
15. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.