CancerPhase 1NCT01191775
A Study of PNT2258 in Patients With Advanced Solid Tumors
A Phase 1 study testing PNT2258 in people with Cancer and Lymphoma, run by Sierra Oncology LLC - a GSK company at 1 site in United States.
Trial summary
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lymphoma, Prostate Cancer
- What is being tested?
- PNT2258
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2012
- 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
- Histologically confirmed, malignant solid tumor (measurable or non-measurable disease) and cannot be a candidate for known regimens or protocol treatments of higher efficacy or priority.
- Recovered to Grade 1 from all acute toxicities of prior therapies, except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk.
- ECOG performance status of 0, 1, or 2.
- At least 18 years of age.
- Patients must have normal organ and marrow function as defined by:
- Absolute neutrophil count 1,500/µL
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- Platelets 100,000/µL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) 2.5 x institutional upper limit of normal (ULN) or 5.0 x ULN in patients with liver metastases
- Serum creatinine 1.5 x ULN or measured creatinine clearance of 60 mL/min/1.73 m2.
- Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods is required during the study.
- Ability to understand the requirements of the study. Must provide written informed consent and authorization of use and disclosure of protected health information. Must agree to abide by the study restrictions and to return for the required assessments.
Who cannot join
- Received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.
- Receiving any other investigational agents.
- Known brain metastases with the exception of patients with a history of treated brain metastases who are stable for at least 3 months off glucocorticoids and seizure medications.
- Prolongation of QT/QTc interval > 450 milliseconds (ms).
- Known HIV, HBV, or HCV infection.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PNT2258.
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- History of allergic reaction to egg or chicken antigens.
- Pregnant or nursing women.
- Uncontrolled intercurrent illness including, but not limited to ongoing or serious active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.
Read the detailed description
This study is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). At first, patients will be treated in single patient cohorts following an accelerated titration design and evaluated for toxicities. After the accelerated portion ends, patients will be treated in cohorts of at least 3 patients at each dose level and evaluated for treatment-related toxicities.
- Conditions
- Cancer, Lymphoma, Prostate Cancer, Melanoma
- Being tested
- PNT2258
- Keywords
- Oligonucleotide, DNAi, Oncology, Antineoplastic agent, Lymphoma, PNT2258
- Medical subject headings
- Neoplasms, Lymphoma, Prostatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNT2258Drug
Also called PNT-2258
Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| PNT2258 | Experimental | PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome. Receives: Drug: PNT2258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of PNT2258 in patients with advanced solid tumors
Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose
Measured: Ongoing
Secondary outcomes (1)
Pharmacokinetic profile of PNT2258
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2012
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 CancerStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony W Tolcher, MD, FRCP(C), Principal investigator, South Texas Accelerated Research Therapeutics (START)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191775
- Sponsor's protocol ID
- P06-10091 (PNT2258-01)
- Status last verified
- Jan 2017
- First submitted
- 27 Aug 2010
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tolcher AW, Rodrigueza WV, Rasco DW, Patnaik A, Papadopoulos KP, Amaya A, Moore TD, Gaylor SK, Bisgaier CL, Sooch MP, Woolliscroft MJ, Messmann RA. A phase 1 study of the BCL2-targeted deoxyribonucleic acid inhibitor (DNAi) PNT2258 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Feb;73(2):363-71. doi: 10.1007/s00280-013-2361-0. Epub 2013 Dec 3.
PubMed 24297683
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01191775
- Acronym / sponsor ID
- P06-10091 (PNT2258-01)
- Conditions
- Cancer, Lymphoma, Prostate Cancer, Melanoma
- Keywords
- Oligonucleotide, DNAi, Oncology, Antineoplastic agent, Lymphoma, PNT2258
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sierra Oncology LLC - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 Aug 2010 (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 study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.
Detailed description
This study is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). At first, patients will be treated in single patient cohorts following an accelerated titration design and evaluated for toxicities. After the accelerated portion ends, patients will be treated in cohorts of at least 3 patients at each dose level and evaluated for treatment-related toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNT2258 | Experimental | Drug: PNT2258PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed, malignant solid tumor (measurable or non-measurable disease) and cannot be a candidate for known regimens or protocol treatments of higher efficacy or priority.
- Recovered to Grade 1 from all acute toxicities of prior therapies, except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk.
- ECOG performance status of 0, 1, or 2.
- At least 18 years of age.
- Patients must have normal organ and marrow function as defined by:
Key exclusion criteria (9 listed)
- Received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.
- Receiving any other investigational agents.
- Known brain metastases with the exception of patients with a history of treated brain metastases who are stable for at least 3 months off glucocorticoids and seizure medications.
- Prolongation of QT/QTc interval > 450 milliseconds (ms).
- Known HIV, HBV, or HCV infection.
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 |
|---|---|---|
| PNT2258Also: PNT-2258Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study. | Drug | PNT2258 |
Primary outcome
To determine the safety of PNT2258 in patients with advanced solid tumors
Time frame: Ongoing
Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose
1 secondary outcome
Pharmacokinetic profile of PNT2258
Time frame: Ongoing
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 19 Apr 2023.
- Background: PubMed 24297683Tolcher AW, Rodrigueza WV, Rasco DW, Patnaik A, Papadopoulos KP, Amaya A, Moore TD, Gaylor SK, Bisgaier CL, Sooch MP, Woolliscroft MJ, Messmann RA. A phase 1 study of the BCL2-targeted deoxyribonucleic acid inhibitor (DNAi) PNT2258 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Feb;73(2):363-71. doi: 10.1007/s00280-013-2361-0. Epub 2013 Dec 3.
- Sponsor's Web SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anthony W Tolcher, MD, FRCP(C) principal investigator
South Texas Accelerated Research Therapeutics (START)
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 PNT2258 in people with Cancer and Lymphoma, run by Sierra Oncology LLC - a GSK company 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 12 inclusion and 9 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 19 Apr 2023. 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?
To determine the safety of PNT2258 in patients with advanced solid tumors (time frame: Ongoing). 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 NCT01191775, 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 19 Apr 2023.