Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Solid Tumors, Prostate Cancer

In brief

This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.

Key facts

Study ID

NCT01497925

Run by

Polaris Group

People needed

43

Starts

2011-09-06

Expected to finish

2018-08-31

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• (Dose-Escalation Phase)
• Pregnant or breastfeeding women. The effects of these drugs on the unborn fetus are unknown. Documentation of a negative serum pregnancy test is required for all women of reproductive potential.
• Patient has a clinically significant concurrent illness. Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
• Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.
• Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Prior therapy with ADI-PEG 20 or docetaxel.
• Allergy to pegylated compounds or study drugs.
• Exclusion Criteria: MTD Expansion Phase Cohort 1 - CRPC
• Patient has a clinically significant concurrent illness. Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
• Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.
• Patient has a history of allergy or hypersensitivity to the study drug or a taxane.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Prior therapy with ADI-PEG 20 or docetaxel.
• Allergy to pegylated compounds.

Where it is running

• University of California at Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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