Colorectal CancerPhase 1/2NCT00149396
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver
A Phase 1/2 study testing NV1020 in people with Colorectal Cancer and Liver Neoplasms, run by MediGene at 5 sites in United States.
Trial summary
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Neoplasms
- What is being tested?
- NV1020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2004to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to understand and willingness to sign a written informed consent (includes willingness to avoid physical intimacy during and for 2 weeks post NV1020 treatment)
- 18 years or more of age
- Colorectal adenocarcinoma histologically confirmed within one year prior to enrollment in the study
- Liver dominant metastases (CT-measurable lesions with less than 50% total liver involvement), histologically confirmed
- Failed conventional chemotherapy for metastatic disease (e.g. tumors no longer responding to 5-FU/leucovorin in combination with irinotecan or oxaliplatin with or without one monoclonal antibody)
- Candidate for additional chemotherapy (and/or experimental anti-cancer therapy, if this is the only remaining treatment option)
Show all 11Show fewer
- Karnofsky Performance Status 70% or greater
- Life expectancy greater than or equal to 4 months, based on the investigator's opinion
- Seropositive for herpes simplex virus-1 (HSV-1)
- Fecund females: negative for pregnancy test (urine or serum)
- Effective double-barrier contraception for a minimum of 2 months following final infusion of NV1020
Who cannot join
- Dominant extrahepatic disease, including cerebral metastases, significant malignant ascites or other extrahepatic metastases that are symptomatic, in critical locations or otherwise likely to confound NV1020 evaluations, in the opinion of the investigator
- Seronegative for HSV-1
- Significant active/unstable non-malignant disease or laboratory test (hematology and chemistry) results that meet any of the following:
- White blood cell count (WBC) less than or equal to 3 x 10e3/mm3
- Absolute neutrophil count (ANC) less than or equal to 1.5 x 10e3/mm3
- Platelets less than or equal to 100,000/mm3
Show all 28Show fewer
- Hemoglobin (Hgb) less than or equal to 9.0 g/dL
- Prothrombin time/partial thromboplastin time (PT/PTT) > upper limit of normal (ULN)
- Serum creatinine > 2.0 mg/dL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times ULN or total bilirubin > 1.5 times ULN
- Alkaline phosphatase > 2.5 times ULN
- Chemotherapy < 4 weeks prior to the first NV1020 infusion (mitomycin or nitrosurea < 6 weeks)
- Immunotherapy < 6 weeks prior to the first NV1020 infusion
- Radiotherapy (external or internal) to the liver
- Major surgery (excluding pump placement and cholecystectomy) ≤ 2 weeks prior to the first NV1020 infusion but the subject must be clinically stable. Pump placement and cholecystectomy ≤ 1 week prior to the first NV1020 infusion but the subject must be clinically stable
- Female who is pregnant or nursing
- Patients wishing to conceive within 2 months after the last infusion of NV1020
- Any investigational agent administered less than or equal to 4 weeks prior to NV1020 infusion
- Acute HSV infection requiring systemic antiviral therapy or history of serious HSV infection (e.g., ocular, encephalitic, etc.)
- Active viral hepatitis (evidence for infection with hepatitis A, B or C viruses)
- Known infection with HIV
- Known hypersensitivity to any component of the NV1020 formulation
- History of, or current, bleeding or coagulation disorder
- History of significant hepatic fibrosis, cirrhosis, or hemachromatosis
- History of malignancy other than colorectal cancer, within 5 years prior to start of study participation, with the exception of in situ cervical or skin carcinoma
- Active severe infection and any other concurrent disease or medical conditions that are likely to interfere with the study, as judged by the investigator
- Systemic corticosteroid administration < 4 weeks prior to starting NV1020 treatment
- Prior treatment with NV1020 or other putative oncolytic viruses
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mary Crowley Medical Research Center
Dallas, Texas, 75201
University of Vanderbilt
Nashville, Tennessee, 37232
University of Pittsburgh Cancer Center
Pittsburgh, Pennsylvania, 15213
University of California, San Diego
San Diego, California, 92093
About this study
Official title: A Phase I/II, Open-label Study to Evaluate the Safety and Anti-tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.
Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.
Read the detailed description
This study is designed to evaluate the effects of repeated treatments with NV1020, prior to second-line chemotherapy, and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies.
Sequential, open-label cohort dose escalation of NV1020 (stage 1) followed by an expansion of one selected dose cohort (stage 2).
Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation.
During the dose escalation stage, 3 cohorts of patients (3 in each) will be treated with 4 fixed doses of NV1020, with the dose level increasing for successive cohorts. A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020. The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions. One additional cohort (half log higher increment) may be approved by the DSMB, if considered necessary to define MTD. Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected.
In the second stage of the study, the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients. For all patients in this study, investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator.
All patients will be followed up periodically until death. Permission for autopsy will be sought.
- Conditions
- Colorectal Cancer, Liver Neoplasms
- Being tested
- NV1020
- Keywords
- Colorectal cancer metastases to liver, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Colorectal Neoplasms, Rectum Cancer, Rectum tumors, Rectum carcinoma, Colon cancer, Colon tumors, Colon carcinoma, Rectum Neoplasms, Colon Neoplasms, Liver Neoplasms, Hepatic Neoplasms, Liver Tumors, Liver cancer, Hepatic Cancer, Hepatic tumors, metastatic to the liver
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NV1020Drug
NV1020 dose levels: 3x10^6, 1x10^7, 3x10^7, and 1x10^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Safety and antitumor effects of NV1020 | Experimental | Stage 1: Four escalating dose cohorts of NV1020 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, and 1x10^8 pfu administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.
Stage 2: Expansion of one dose cohort from Stage 1 of optimal NV1020 dose administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy. Receives: Drug: NV1020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Dose Limiting Adverse Events
Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
Measured: From start of treatment through 12 months after completion of treatment
NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin
Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)
Measured: Daily for 2 weeks after the first and last NV1020 infusions
Clinical Laboratory Safety - Hematology
Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)
Measured: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Clinical Laboratory Safety - Chemistry
Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort
Measured: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Clinical Laboratory Safety - Coagulation
Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort
Measured: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Secondary outcomes (7)
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Measured: Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M)
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Maximum percentage changes in tumor diameter after administration of NV1020 followed by chemotherapy as measured by CT scan and Modified Response Evaluation Criteria in Solid Tumors (RECIST) assessment
Measured: Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort
Measured: Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Time to Disease Progression; Survival Time
Progression assessed from CT and PET measurements and is determined as an increase of greater than or equal to 25% in the sum of the products of perpendicular diameters of all tumors, or the appearance of any new lesion.
Measured: Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Measured: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Measured: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)
Measured: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoda Tawfik, PhD, Study director, MediGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149396
- Sponsor's protocol ID
- CT1030
- Status last verified
- Mar 2018
- First submitted
- 6 Sep 2005
- Last updated
- 24 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sze DY, Iagaru AH, Gambhir SS, De Haan HA, Reid TR. Response to intra-arterial oncolytic virotherapy with the herpes virus NV1020 evaluated by [18F]fluorodeoxyglucose positron emission tomography and computed tomography. Hum Gene Ther. 2012 Jan;23(1):91-7. doi: 10.1089/hum.2011.141. Epub 2011 Oct 14.
PubMed 21895536
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Study to Evaluate the Safety and Anti-tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver
- ClinicalTrials.gov ID
- NCT00149396
- Acronym / sponsor ID
- CT1030
- Conditions
- Colorectal Cancer, Liver Neoplasms
- Keywords
- Colorectal cancer metastases to liver, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Colorectal Neoplasms, Rectum Cancer, Rectum tumors, Rectum carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 24 Apr 2018
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 an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.
Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.
Detailed description
This study is designed to evaluate the effects of repeated treatments with NV1020, prior to second-line chemotherapy, and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies.
Sequential, open-label cohort dose escalation of NV1020 (stage 1) followed by an expansion of one selected dose cohort (stage 2).
Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation.
During the dose escalation stage, 3 cohorts of patients (3 in each) will be treated with 4 fixed doses of NV1020, with the dose level increasing for successive cohorts. A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020. The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions. One additional cohort (half log higher increment) may be approved by the DSMB, if considered necessary to define MTD. Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected.
In the second stage of the study, the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients. For all patients in this study, investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator.
All patients will be followed up periodically until death. Permission for autopsy will be sought.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and antitumor effects of NV1020 | Experimental | Drug: NV1020Stage 1: Four escalating dose cohorts of NV1020 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, and 1x10^8 pfu administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy. Stage 2: Expansion of one dose cohort from Stage 1 of optimal NV1020 dose administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and willingness to sign a written informed consent (includes willingness to avoid physical intimacy during and for 2 weeks post NV1020 treatment)
- 18 years or more of age
- Colorectal adenocarcinoma histologically confirmed within one year prior to enrollment in the study
- Liver dominant metastases (CT-measurable lesions with less than 50% total liver involvement), histologically confirmed
- Failed conventional chemotherapy for metastatic disease (e.g. tumors no longer responding to 5-FU/leucovorin in combination with irinotecan or oxaliplatin with or without one monoclonal antibody)
Key exclusion criteria (28 listed)
- Dominant extrahepatic disease, including cerebral metastases, significant malignant ascites or other extrahepatic metastases that are symptomatic, in critical locations or otherwise likely to confound NV1020 evaluations, in the opinion of the investigator
- Seronegative for HSV-1
- Significant active/unstable non-malignant disease or laboratory test (hematology and chemistry) results that meet any of the following:
- Chemotherapy < 4 weeks prior to the first NV1020 infusion (mitomycin or nitrosurea < 6 weeks)
- Immunotherapy < 6 weeks prior to the first NV1020 infusion
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 |
|---|---|---|
| NV1020NV1020 dose levels: 3x10^6, 1x10^7, 3x10^7, and 1x10^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks | Drug | Safety and antitumor effects of NV1020 |
Primary outcome
Incidence of Adverse Events and Dose Limiting Adverse Events
Time frame: From start of treatment through 12 months after completion of treatment
Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin
Time frame: Daily for 2 weeks after the first and last NV1020 infusions
Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)
Clinical Laboratory Safety - Hematology
Time frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)
Clinical Laboratory Safety - Chemistry
Time frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort
Clinical Laboratory Safety - Coagulation
Time frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment
Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort
7 secondary outcomes
Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy
Time frame: Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M)
Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment
Time frame: Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay
Time frame: Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)
Time to Disease Progression; Survival Time
Time frame: Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient
Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)
Time frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)
Time frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)
Time frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21895536Sze DY, Iagaru AH, Gambhir SS, De Haan HA, Reid TR. Response to intra-arterial oncolytic virotherapy with the herpes virus NV1020 evaluated by [18F]fluorodeoxyglucose positron emission tomography and computed tomography. Hum Gene Ther. 2012 Jan;23(1):91-7. doi: 10.1089/hum.2011.141. Epub 2011 Oct 14.
- 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.
Hoda Tawfik, PhD study director
MediGene
5 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 NV1020 in people with Colorectal Cancer and Liver Neoplasms, run by MediGene at 5 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 11 inclusion and 28 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 24 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Adverse Events and Dose Limiting Adverse Events (time frame: From start of treatment through 12 months after completion of treatment). The study lists 5 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 NCT00149396, 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 24 Apr 2018.