CancerPhase 1/2NCT01262235
A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
A Phase 1/2 study testing TKM-080301 in people with Cancer and Neuroendocrine Tumors, run by Arbutus Biopharma Corporation at 8 sites in United States.
Trial summary
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Neuroendocrine Tumors, NET
- What is being tested?
- TKM-080301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2010to Aug 2015
- Phase
- Phase 1/2
- 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
- Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.
- Patient has an ECOG performance status of 0 - 1,
- Patient has adequate hematologic, hepatic and renal function,
- Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),
- Patients must have a life expectancy of at least 12 weeks.
Who cannot join
- Unresolved toxicities (> Grade 1) of previous chemotherapy,
- Patients with primary tumors of the central nervous system (CNS),
- Prophylactic hematologic growth factors administered </= 2 weeks prior to start of therapy,
- Patient has history of or existing clinically significant cardiovascular disease,
- Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
- Patient has a seizure disorder not controlled on medication,
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- Patient has a known or suspected viral, parasitic, or fungal infection,
- Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,
- Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-2800
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Westchase Oncology Center
Houston, Texas, 77042
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Mayo Clinic
Rochester, Minnesota, 55905
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
- Conditions
- Cancer, Neuroendocrine Tumors, NET, Adrenocortical Carcinoma, ACC
- Being tested
- TKM-080301
- Keywords
- Solid tumor, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Neuroendocrine tumors (NET), Adrenocortical carcinoma (ACC), Carcinoid
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors, Adrenocortical Carcinoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKM-080301Drug
Also called PLK1 SNALP, TKM-PLK1
Repeat dose IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TKM-080301 | Experimental | Not described Receives: Drug: TKM-080301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of treatment with TKM-080301
Measured: 6 months
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301
Measured: 6 months
Secondary outcomes (2)
Characterize the pharmacokinetics of TKM-080301
Measured: 2 months
Assess preliminary evidence of anti-tumor activity
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 posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kowalski, MD, Study director, Tekmira Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262235
- Sponsor's protocol ID
- TKM-PLK1-001
- Status last verified
- Jan 2019
- First submitted
- 15 Dec 2010
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01262235
- Acronym / sponsor ID
- TKM-PLK1-001
- Conditions
- Cancer, Neuroendocrine Tumors, NET, Adrenocortical Carcinoma, ACC
- Keywords
- Solid tumor, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Neuroendocrine tumors (NET), Adrenocortical carcinoma (ACC), Carcinoid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Dec 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 will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKM-080301 | Experimental | Drug: TKM-080301 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.
- Patient has an ECOG performance status of 0 - 1,
- Patient has adequate hematologic, hepatic and renal function,
- Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),
- Patients must have a life expectancy of at least 12 weeks.
Key exclusion criteria (9 listed)
- Unresolved toxicities (> Grade 1) of previous chemotherapy,
- Patients with primary tumors of the central nervous system (CNS),
- Prophylactic hematologic growth factors administered </= 2 weeks prior to start of therapy,
- Patient has history of or existing clinically significant cardiovascular disease,
- Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
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 |
|---|---|---|
| TKM-080301Also: PLK1 SNALP, TKM-PLK1Repeat dose IV infusion. | Drug | TKM-080301 |
Primary outcome
Safety and tolerability of treatment with TKM-080301
Time frame: 6 months
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301
Time frame: 6 months
2 secondary outcomes
Characterize the pharmacokinetics of TKM-080301
Time frame: 2 months
Assess preliminary evidence of anti-tumor activity
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 16 Jan 2019.
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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 Kowalski, MD study director
Tekmira Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TKM-080301 in people with Cancer and Neuroendocrine Tumors, run by Arbutus Biopharma Corporation at 8 sites 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 5 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of treatment with TKM-080301 (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?
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 16 Jan 2019.