Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01358227
A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors
A Phase 1 study testing PR104 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 2 sites in New Zealand.
Trial summary
The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- PR104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Dec 2006to Jan 2010
- 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
- Age 18 years or more
- Histologically confirmed malignancy for which no effective therapy exists
- Measurable or evaluable disease
- ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for definition of ECOG Performance Status 0 and 1
- Ability to read, understand and provide written informed consent
- If the subject is on systemic steroids, the dose of steroids must be stable for at least two weeks prior to the first dose of PR-104
Who cannot join
- Licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study
- Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens
- Absolute neutrophil count of < 1.5 x 109/L
- Platelet count of < 100 x 109/L
- Hemoglobin level of < 90 g/L (or requiring a red blood cell transfusion to maintain hemoglobin > 90 g/L)
- Serum bilirubin greater than the upper limit of normal
Show all 16Show fewer
- ALT and AST greater than 2.5 times the upper limit of normal
- Serum creatinine less than 1.5 times upper limit of normal
- Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) greater than 1.1 times the upper limit of normal range
- Women who are pregnant, breast-feeding or planning to become pregnant during the study
- Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication. See section 5.11 (Contraceptives) for definition of effective methods of contraception
- Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during study participation, including uncontrolled infection or infection requiring a concomitant parenteral antibiotic
- Plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy) while on study
- Less than four weeks since major surgery
- Known to be HIV positive, Hepatitis B sAg positive or Hepatitis C positive with abnormal liver function tests
- No known contraindication to single doses of naproxen
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
University of Auckland
Auckland
Waikato Hospital
Waikato
About this study
Official title: A Phase I, Multi-center, Open-label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given Weekly in Subjects With Solid Tumors
The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.
- Being tested
- PR104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR104Drug
Dose escalation of PR104 to determine maximum tolerated dose for weekly administration
| Study group | Role | What they receive |
|---|---|---|
| PR104 | Experimental | Not described Receives: Drug: PR104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) of PR104 when administered weekly
MTD is based on cycle 1 data and defined as the maximum dose that can be administered to 6 subjects with no more than one of the following DLTs:
- Grade 4 thrombocytopenia
- Grade 4 heme toxicity (excluding thrombocytopenia) that lasts for ≥ 5 days (Neutrophils < 500/mm3, ANC ≤ 0.5 K/mm3, lymphocytes < 1K/mm3, HGB < 6.5 gm/dL)
- Non-heme toxicity ≥ Grade 3 despite appropriate treatment
- Neutropenic fever
- Grade 2 or higher neurotoxicity of ≥ 1 week
- Any toxicity of Grade 2 or higher that has not resolved within 2 weeks of end of cycle 1 (except grade 2 alopecia)
Measured: 4 weeks (cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proacta, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark McKeage, PhD, FRACP, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358227
- Sponsor's protocol ID
- PR104-1002
- Status last verified
- May 2011
- First submitted
- 18 May 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given Weekly in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01358227
- Acronym / sponsor ID
- PR104-1002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Proacta, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 May 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.
The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PR104 | Experimental | Drug: PR104 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or more
- Histologically confirmed malignancy for which no effective therapy exists
- Measurable or evaluable disease
- ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for definition of ECOG Performance Status 0 and 1
- Ability to read, understand and provide written informed consent
Key exclusion criteria (16 listed)
- Licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study
- Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens
- Absolute neutrophil count of < 1.5 x 109/L
- Platelet count of < 100 x 109/L
- Hemoglobin level of < 90 g/L (or requiring a red blood cell transfusion to maintain hemoglobin > 90 g/L)
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 |
|---|---|---|
| PR104Dose escalation of PR104 to determine maximum tolerated dose for weekly administration | Drug | PR104 |
Primary outcome
Determine the maximum tolerated dose (MTD) of PR104 when administered weekly
Time frame: 4 weeks (cycle 1)
MTD is based on cycle 1 data and defined as the maximum dose that can be administered to 6 subjects with no more than one of the following DLTs: * Grade 4 thrombocytopenia * Grade 4 heme toxicity (excluding thrombocytopenia) that lasts for ≥ 5 days (Neutrophils < 500/mm3, ANC ≤ 0.5 K/mm3, lymphocytes < 1K/mm3, HGB < 6.5 gm/dL) * Non-heme toxicity ≥ Grade 3 despite appropriate treatment * Neutropenic fever * Grade 2 or higher neurotoxicity of ≥ 1 week * Any toxicity of Grade 2 or higher that has not resolved within 2 weeks of end of cycle 1 (except grade 2 alopecia)
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 24 May 2011.
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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.
Mark McKeage, PhD, FRACP principal investigator
University of Auckland, New Zealand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PR104 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 2 sites in New Zealand.
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 6 inclusion and 16 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 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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?
Determine the maximum tolerated dose (MTD) of PR104 when administered weekly (time frame: 4 weeks (cycle 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2011.