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A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Lymphoma

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies


Inclusion Criteria:



1. The subject has a histologically confirmed advanced malignancy (solid tumor or
lymphoma) that is metastatic or unresectable, and for which standard curative or
palliative measures do not exist or are no longer effective, and there are no
therapies known to prolong survival.

2. The subject has disease that is assessable by tumor marker, physical, or radiologic
means.

3. The subject is ≥18 years old.

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

5. The subject has adequate organ and marrow function.

6. The subject has the capability of understanding the informed consent document and has
signed the informed consent document.

7. Sexually active subjects (male and female) must use medically acceptable methods of
contraception during the course of the study.

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

9. If a subject has received more than three prior regimens of cytotoxic chemotherapy,
more than two biologic regimens, or more than 3000 cGy to >25% of his or her bone
marrow, the investigator must discuss with the sponsor regarding subject suitability
before enrollment.

10. The subject has had no other diagnosis of malignancy (unless non-melanoma skin
cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, and
has had no evidence of disease for 5 years prior to screening for this study).

Exclusion Criteria:

1. The subject has received anticancer treatment (eg, chemotherapy, radiotherapy,
immunotherapy, biologic therapy, investigational agent, or hormones) within 14 days
prior to the first dose of study drug.

2. The subject has not recovered to Grade ≤1 from adverse events (AEs) due to
investigational agents or other medications administered more than 30 days prior to
the first dose of study drug.

3. The subject has received radiation to >25% of his or her bone marrow within 30 days
of XL844 treatment.

4. The subject has a primary brain tumor or known brain metastases.

5. The subject has uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, hypertension, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

6. The subject is pregnant or breastfeeding.

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

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

9. The subject has a known allergy or hypersensitivity to any of the components of the
XL844 formulation or gemcitabine.

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 and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies

Outcome Time Frame:

Assessed at each visit/periodic visits

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL844-002

NCT ID:

NCT00475917

Start Date:

May 2007

Completion Date:

May 2009

Related Keywords:

  • Cancer
  • Lymphoma
  • Advanced malignancies
  • Solid tumor
  • Neoplasms
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
M.D. Anderson Cancer CenterHouston, Texas  77030