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A Phase 1b/2a Open-Label Study to Evaluate the Safety and Activity of Once Daily Oral Administration of Tivozanib (AV-951) in Subjects With Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase 1b/2a Open-Label Study to Evaluate the Safety and Activity of Once Daily Oral Administration of Tivozanib (AV-951) in Subjects With Non-Small Cell Lung Cancer


The Phase 2a portion of the study was not conducted


Inclusion Criteria:



1. Age 18 years or older, of either sex and of any race.

2. Histologically or cytologically confirmed NSCL.

3. Stage IIIB (with malignant pleural effusion) or stage IV or recurrent disease.

4. Subjects that have recurred or progressed following standard therapy or failed
standard therapy; or subjects that are not candidates for or unwilling to undergo
standard therapy.

5. Disease that is currently not amenable to curative surgical intervention, due to
either non-resectability of the tumor or medical contraindications.

6. Prior VEGF directed therapy

7. Prior chemotherapy

8. At least 4 weeks since prior immunotherapy (eg, IL-2, IFN, etc.) or biological
therapy (eg, MABs) prior to the first dose of study drug.

9. At least 1 week since prior treatment with warfarin, acenocoumarol, fenprocoumon, or
similar agents.

10. At least 4 weeks since prior systemic hormonal therapy.

11. At least 2 weeks since prior use of herbal preparations/supplements.

12. At least 2 weeks since prior treatment with CYP3A4 inducers or inhibitors.

13. At least 2 weeks since prior radiotherapy to ≤25% of bone marrow, or at least 4 weeks
since prior radiotherapy to > 25% of bone marrow.

14. Measurable or evaluable disease; subjects enrolled in the Phase 2a study must have
measurable disease by RECIST criteria.

15. ECOG performance 0-1 and life expectancy ≥ 3 months.

16. Ability to give written informed consent.

Exclusion Criteria:

1. Subjects with central lung lesions involving major blood vessels.

2. Primary CNS malignancies or symptomatic CNS metastases; subjects with previously
treated brain metastasis will be allowed if the brain metastasis have been stable
without steroid treatment for at least 3 months following prior treatment
(radiotherapy or surgery).

3. Hematologic malignancies (including leukemia in any form, lymphoma, and multiple
myeloma).

4. Hematologic abnormalities:

5. Serum chemistry abnormalities:

6. Significant cardiovascular disease

7. Subjects with delayed healing of wounds, active gastric ulcers, or unhealed bone
fractures.

8. Serious/active infection or infection requiring parenteral antibiotics.

9. Inadequate recovery from any prior surgical procedure or major surgical procedure
within 6 weeks prior to administration of first dose of study drug.

10. Inability to comply with protocol requirements.

11. History of ≥ Grade 2 hemoptysis within 6 months prior to administration of first dose
of study drug; ongoing bleeding (hemoptysis, hematemesis, hematochezia or melena) or
history of clinically significant bleeding within 6 months prior to administration of
first dose of study drug.

12. Cerebrovascular accident within 12 months prior to administration of first dose of
study drug, or peripheral vascular disease with claudication on walking less than 1
block.

13. Deep venous thrombosis or pulmonary embolus within 6 months prior to administration
of first dose of study drug.

14. Subjects with a "currently active" second primary malignancy other than non-melanoma
skin cancers or nonmetastatic prostate cancer. Subjects are not considered to have a
"currently active" malignancy if they have completed anti-cancer therapy and have
been disease free for >2 years.

15. If female, pregnant or lactating.

16. No childbearing potential or the use of effective contraception by all fertile male
and female subjects during the study and for 30 days after the last dose of study
drug. All subjects must agree to use a highly effective method of contraception
(including their partner).

17. Known concomitant genetic or acquired immune suppression disease such as HIV.

18. Inadequate recovery from prior antineoplastic therapy.

19. Life-threatening illness or organ system dysfunction compromising safety evaluation.

20. Psychiatric disorder, altered mental status precluding informed consent or necessary
testing.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ph1b: To determine the safety, tolerability, and MTD of tivozanib (AV-951) administered orally QD in subjects with NSCLC

Outcome Time Frame:

4 weeks (1 cycle)

Safety Issue:

Yes

Principal Investigator

Jaroslaw Jac, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

AVEO Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AV-951-08-105

NCT ID:

NCT00826878

Start Date:

January 2009

Completion Date:

May 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • tivozanib
  • AV-951
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Georgetown UniversityWashington, District of Columbia  20007-2197
Kansas University Medical CenterKansas City,, Kansas  66160-7390
Memorial Sloan-KetteringNew York, New York