Trial Search Results

A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols

Open-label, multi-center, multi-national rollover study to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule as per the original (parent) protocol. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the (original) parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be recorded. CT scans to assess disease will be performed at the end of even-numbered cycles (Cycle 2, Cycle 4, etc).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AVEO Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Tivozanib + paclitaxel
  • Drug: Tivozanib + temsirolimus
  • Drug: Tivozanib
  • Drug: Tivozanib (AV-951)
  • Drug: Tivozanib + capecitabine
  • Drug: Tivo

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. The subject must have received tivozanib while enrolled in another protocol, must be
   tolerating study drug and must currently display clinical benefit. The length of time
   that a subject must be on the parent protocol before rolling over to this protocol
   will be dictated by the parent protocol.

   2. If female and of childbearing potential, documentation of negative pregnancy test
   prior to enrollment.

   3. Ability to give written informed consent.

Exclusion Criteria:

   1. > 4 weeks since discontinuation of tivozanib treatment on a previous protocol

   2. If female, pregnant or lactating

   3. Sexually active male and pre-menopausal female subjects (and their partners) unless
   they agree to use adequate contraceptive measures, while on study and for 30 days
   after the last dose of study drug. All fertile male and female subjects (and their
   partners) must agree to use a highly effective method of contraception. Highly
   effective birth control includes (a) IUD plus one barrier method; or (b) 2 barrier
   methods. Effective barrier methods are male or female condoms, diaphragms, and
   spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral,
   implantable, or injectable contraceptives may be affected by cytochrome P450
   interactions, and are not considered effective for this study.)

   4. Uncontrolled hypertension: systolic blood pressure > 140 mmHg or diastolic blood
   pressure >90 mmHg on 2 or more antihypertensive medications, documented on 2
   consecutive measurements taken at least 24 hours apart.

   5. Newly identified CNS malignancies or documented progression of CNS metastases;
   subjects will be allowed only if the CNS metastases have been adequately treated with
   radiotherapy or surgery. For subjects receiving steroid therapy please refer to
   Section 6.3 for allowed steroid maintenance therapy.

   6. Unhealed wounds (including active peptic ulcers)

   7. Serious/active infection or infection requiring parenteral antibiotics

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

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

10. Inability to comply with protocol requirements

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting