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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Neoplasm

Treatments

Drug: PF-00337210

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01105533

A8051001

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 10 patient groups

Cohort 1

Experimental group

Treatment:

Drug: PF-00337210

Cohort 2

Experimental group

Treatment:

Drug: PF-00337210

Cohort 3

Experimental group

Treatment:

Drug: PF-00337210

Cohort 4

Experimental group

Treatment:

Drug: PF-00337210

Cohort 5

Experimental group

Treatment:

Drug: PF-00337210

Cohort 6

Experimental group

Treatment:

Drug: PF-00337210

Cohort 7

Experimental group

Treatment:

Drug: PF-00337210

Cohort 8

Experimental group

Treatment:

Drug: PF-00337210

Cohort 9

Experimental group

Treatment:

Drug: PF-00337210

Cohort 10

Experimental group

Treatment:

Drug: PF-00337210

Trial contacts and locations

3

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