A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-09-30

Brief Summary

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This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.

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Detailed Description

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Conditions

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Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous

Cohort 2

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

1mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 3

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

2mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 4

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

4mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 5

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

6mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 6

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

9mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 7

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

8mg Capsule Once Daily (Dose Escalation) Continuous

Cohort 8

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

4mg Capsule Twice Daily (Dose Escalation) Continuous

Cohort 9

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

6mg Capsule Twice Daily (Dose Escalation) Continuous

Cohort 10

Group Type EXPERIMENTAL

PF-00337210

Intervention Type DRUG

6mg Capsule Twice Daily (Dose Expansion) Continuous

Interventions

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PF-00337210

0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

1mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

2mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

4mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

6mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

9mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

8mg Capsule Once Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

4mg Capsule Twice Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

6mg Capsule Twice Daily (Dose Escalation) Continuous

Intervention Type DRUG

PF-00337210

6mg Capsule Twice Daily (Dose Expansion) Continuous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
* At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors \[RECIST\].
* Adequate bone marrow, liver function and renal function as defined by protocol.
* Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.

During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

Exclusion Criteria

* Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
* Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
* Patients with carcinomatous meningitis or un-treated brain metastases.
* Any acute cardiovascular incident within the past 12 months.
* Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
* Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No