Solid TumorsPhase 1NCT01497925
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
A Phase 1 study testing ADI-PEG 20 in people with Solid Tumors and Prostate Cancer, run by Polaris Group at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Prostate Cancer
- What is being tested?
- ADI-PEG 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2011to 31 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the dose-escalation phase, patients must have cytologically or histologically proven advanced malignant solid tumors, with emphasis on CRPC.
- Patients must be 18 years of age or older.
- Patients must have a Zubrod (ECOG) performance status of 0-2.
- Patients must have an estimated survival of at least 3 months.
- Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible side effects of prior chemotherapy regimens or radiotherapy to < grade 1 (excluding alopecia, lymphopenia, and hyperglycemia) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
- Radiographs (Xrays, CT scans, etc) to follow disease response or progression must have been completed within 28 days prior to registration.
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- Patients must have adequate renal function as documented by a calculated creatinine clearance of > 45 ml/min (see Appendix for formula for calculating creatinine clearance).
- Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of normal, and bilirubin < upper limit of normal.
- All patients must have a histologic diagnosis of adenocarcinoma of the prostate which is measurable or non-measurable.
- Patients must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following (despite androgen deprivation and antiandrogen withdrawal when applicable):
- Progression of measurable disease assessed within 28 days prior to registration.
- Progression of non-measurable disease assessed within 28 days prior to registration.
- Rising PSA - Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA is required to be taken and be greater than the second measure. The patient must have a PSA ≥ 5 ng/ml in addition to increasing PSA to be eligible by rising PSA criteria alone. However, no minimum PSA is required for patients whose progression is based on measurable or non-measurable disease.
- All patients must have a pre-study PSA obtained within 28 days prior to registration.
- All patients must have had imaging studies within 28 days prior to registration. The choice of imaging studies to follow disease will be at the discretion of the investigator.
- Patients must be offered the opportunity to participate in specimen banking for future use (to include the serum and tissue correlative studies).
- Patients must have been surgically or medically castrated. If method of castration is LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists. Patients who have stopped treatment should be willing to restart.
- If the patient has been treated with non-steroidal antiandrogens (flutamide, bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for flutamide, bicalutamide or nilutamide and the patients must have demonstrated progression.
- Prior, planned, or ongoing bisphosphonate therapy or denosumab is allowed.
Who cannot join
- (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.
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- Prior therapy with ADI-PEG 20 or docetaxel.
- Allergy to pegylated compounds or study drugs.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Davis
Sacramento, California, 95817
About this study
Official title: Phase 1 Trial of ADI PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC) and Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
- Conditions
- Solid Tumors, Prostate Cancer
- Being tested
- ADI-PEG 20
- Keywords
- Arginine deiminase, Arginine, Solid tumors, Prostate cancer, Phase 1 study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20Drug
Also called pegylated arginine deiminase
Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 | Experimental | Not described Receives: Drug: ADI-PEG 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: 6 months
Efficacy, as determined by objective response measures
Measured: 6 months
Secondary outcomes (1)
Determine the maximum tolerated dose (MTD) of ADI-PEG 20 with docetaxel
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study start6 Sep 2011
- Primary completion23 Mar 2016
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497925
- Sponsor's protocol ID
- POLARIS2010-001
- Status last verified
- Feb 2018
- First submitted
- 15 Dec 2011
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim RH, Coates JM, Bowles TL, McNerney GP, Sutcliffe J, Jung JU, Gandour-Edwards R, Chuang FY, Bold RJ, Kung HJ. Arginine deiminase as a novel therapy for prostate cancer induces autophagy and caspase-independent apoptosis. Cancer Res. 2009 Jan 15;69(2):700-8. doi: 10.1158/0008-5472.CAN-08-3157.
PubMed 19147587
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of ADI PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC) and Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01497925
- Acronym / sponsor ID
- POLARIS2010-001
- Conditions
- Solid Tumors, Prostate Cancer
- Keywords
- Arginine deiminase, Arginine, Solid tumors, Prostate cancer, Phase 1 study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2011 (actual)
- Primary completion
- 23 Mar 2016 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Drug: ADI-PEG 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For the dose-escalation phase, patients must have cytologically or histologically proven advanced malignant solid tumors, with emphasis on CRPC.
- Patients must be 18 years of age or older.
- Patients must have a Zubrod (ECOG) performance status of 0-2.
- Patients must have an estimated survival of at least 3 months.
- Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible side effects of prior chemotherapy regimens or radiotherapy to < grade 1 (excluding alopecia, lymphopenia, and hyperglycemia) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Key exclusion criteria (14 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG 20Also: pegylated arginine deiminaseDosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly. | Drug | ADI-PEG 20 |
Primary outcome
Number of Participants with Adverse Events
Time frame: 6 months
Efficacy, as determined by objective response measures
Time frame: 6 months
1 secondary outcome
Determine the maximum tolerated dose (MTD) of ADI-PEG 20 with docetaxel
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 19147587Kim RH, Coates JM, Bowles TL, McNerney GP, Sutcliffe J, Jung JU, Gandour-Edwards R, Chuang FY, Bold RJ, Kung HJ. Arginine deiminase as a novel therapy for prostate cancer induces autophagy and caspase-independent apoptosis. Cancer Res. 2009 Jan 15;69(2):700-8. doi: 10.1158/0008-5472.CAN-08-3157.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-PEG 20 in people with Solid Tumors and Prostate Cancer, run by Polaris Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.