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A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL888 in Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL888 in Subjects With Solid Tumors


Inclusion Criteria:



1. Subject has a histologically-confirmed tumor that is metastatic or unresectable and
is no longer responding to therapies known to prolong survival or to other standard
therapies, or has disease for which no effective therapy exists.

2. For subjects enrolling in the maximum tolerated dose expansion cohorts:

- Subject has documented evidence of Her2-overexpressing tumor; OR

- Subject has NSCLC that has progressed after a prior response to erlotinib or
gefitinib; OR

- Subject has histologically-confirmed, metastatic melanoma.

- For subjects in the expansion cohorts A and C: tumor tissue must be accessible
for biopsy and subjects must be willing to undergo tumor biopsy.

3. The subject is ≥ 18 years old.

4. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
2.

5. The subject's weight is ≥ 40 kg.

6. The subject has adequate organ and marrow function.

7. The subject is capable of understanding and complying with the protocol requirements
and has signed the informed consent document.

8. Sexually active subjects (male and female) must use accepted methods of contraception
during the course of the study and for 3 months after the last dose of XL888.

9. Female subjects of childbearing potential must have a negative pregnancy test at
screening.

Exclusion Criteria:

1. The subject has received cytotoxic chemotherapy (including investigational cytotoxic
chemotherapy) or biologic therapy (cytokines, antibodies) within 3 weeks (or
nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL888.

2. The subject has received prior treatment with a small molecule kinase inhibitor
(including an investigational kinase inhibitor) or hormonal therapy within 14 days
before the first dose of XL888.

3. The subject has received any other type of investigational agent within 28 days
before the first dose of study treatment.

4. The subject has a previously-identified allergy or hypersensitivity to components of
the study treatment formulation.

5. The subject has not recovered from clinically-meaningful toxicity due to prior
therapy.

6. The subject has been previously treated with an HSP90 inhibitor

7. The subject has untreated or uncontrolled brain metastases or evidence of
leptomeningeal involvement of disease.

8. The subject is currently receiving anticoagulation with therapeutic dose of warfarin.

9. The subject has uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection; diabetes mellitus; hypertension; symptomatic congestive
heart failure, unstable angina pectoris, stroke or myocardial infarction within 3
months.

10. The subject has a baseline corrected QT interval (QTc) > 460 ms.

11. The subject is pregnant or breastfeeding.

12. The subject is known to be positive for the human immunodeficiency virus (HIV).

13. The subject is unable or unwilling to abide by the study protocol or cooperate fully
with the investigator or designee.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors

Outcome Time Frame:

Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL888-001

NCT ID:

NCT00796484

Start Date:

November 2008

Completion Date:

November 2010

Related Keywords:

  • Cancer
  • Cancer
  • Solid Tumors

Name

Location

South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
Hospital of the University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104