Adult Primary Hepatocellular CarcinomaPhase 1NCT01666756
Chinese Herbal Formulation PHY906 and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer
A Phase 1 study testing Chinese herbal formulation PHY906, sorafenib tosylate and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of Chinese herbal formulation PHY906 when given together with sorafenib tosylate in treating patients with advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Advanced Adult Hepatocellular Carcinoma
- What is being tested?
- Chinese herbal formulation PHY906, sorafenib tosylate and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2014to 29 May 2020
- 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
- Ability to take oral drugs
- Diagnosis of advanced hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) guidelines
- HCC stage B or C according to the Barcelona Clinic Liver Cancer (BCLC)
- Previous or current use of sorafenib allowed
- Measurable disease according to RECIST, i.e. at least one measurable lesion; this lesion should not have been previously treated with local therapy; a treated lesion may be used where these lesions are the only lesions available for evaluation and have shown definite progression since their last local treatment; local therapy must have been completed at least four weeks prior to baseline evaluation
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Show all 18Show fewer
- Cirrhotic status of current Child-Pugh class A and B with no encephalopathy and no ascites (ascites controlled by diuretics is also excluded in this study); Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
- For patients with positive HBV-deoxyribonucleic acid (DNA) and/or positive of hepatitis B surface antigen (HBsAg) results, they must be treated with anti-virals, as prophylaxis at least 1-2 weeks prior to receiving study drug, cycle 1, day 1
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelets >= 75000 x 10^6/L
- Hemoglobin (Hgb) >= 9 g/dL
- Alanine aminotransferase (ALT) =< 5 x upper limit of normal (ULN)
- Serum creatinine =< 1.5 x ULN
- Ability to understand and willingness to sign a written informed consent and to be able to follow the visit schedule
- Life expectancy of approximately 6 months
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for three months following duration of study participation; should a woman become pregnant, or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Previous or current use of sorafenib and previous use of tamoxifen is allowed as previous systemic therapy
Who cannot join
- Patients currently receiving any anti-cancer therapy, except sorafenib, or who have received any local anti-cancer therapy =< 4 weeks prior to baseline computed tomography (CT)/magnetic resonance imaging (MRI) scan, prior to cycle 1 treatment
- Active bleeding during the last 30 days prior to cycle 1 treatment including variceal bleeding (esophageal varices should be treated according to standard practice e.g. ligation/banding and procedure completed 30 days prior to cycle 1 treatment)
- Patients with a known hypersensitivity to KD018 or known hypersensitivity to sorafenib or contraindications to sorafenib based on the local sorafenib label
- Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- Any severe and/or uncontrolled medical conditions including:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to cycle 1 treatment, serious uncontrolled cardiac arrhythmia, uncontrolled hypertension
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- Previous transient ischemic attack (TIA), cerebral vascular accident (CVA), symptomatic posterior vitreous detachment (PVD) within last 6 months of cycle 1 treatment
- Congenital long QT syndrome
- Patients with active alcohol intake
- Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy, in the opinion of the investigator, except chronic HBV or HCV
- Impairment of gastrointestinal function or who have gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- Patients receiving chronic treatment with corticosteroids (except for intermittent topical or local injection or aldosterone) or another immunosuppressive agent
- Patients treated with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A) unless the drugs are medically necessary and no substitutes are available
- Patients who have undergone major surgery =< 2 weeks prior to starting study drug or who have not recovered from surgery
- Patients who have received an investigative drug or therapy within the last 30 days prior to cycle 1 treatment
- Pregnant and/or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Phase I Open Label Study Investigating the Combination of KD018 and Sorafenib (Nexavar) in Patients With Advanced Hepatocellular Carcinoma
This phase I trial studies the side effects and best dose of Chinese herbal formulation PHY906 when given together with sorafenib tosylate in treating patients with advanced liver cancer. Biological therapies, such as Chinese herbal formulation PHY906, may interfere with the growth of tumor cells and slow the growth of tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving Chinese herbal formulation PHY906 together with sorafenib tosylate may work better in treating advanced liver cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize the safety and tolerability of KD018 (Chinese herbal formulation PHY906) in combination with daily sorafenib (sorafenib tosylate) and to determine the maximum tolerated dose (MTD) of the combination of KD018 plus sorafenib to bring forward into phase 2.
SECONDARY OBJECTIVES:
- To describe the efficacy of the combination of KD018 plus sorafenib at the explored dose-levels in terms of best overall response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
II. To assess the safety and tolerability of the combination of KD018 plus sorafenib as measured by the rate and severity of adverse events (AEs).
III. To determine the steady state of sorafenib after KD018 exposure at pre-dose and 1 hour and 2 hours post-dose at the explored combination dose-levels using concentrations at pre-dose (Cmin) and at 1 hour (C1h) and 2 hours (C2h) post-dose.
TERTIARY OBJECTIVES:
- To assess the effect of treatment on soluble markers of angiogenesis, fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), placental growth factor (PLGF), soluble vascular endothelial growth factor receptor 1 (sVEGFR1), sVEGFR2, apoptosis (i.e. M30 monoclonal antibody [M30] and M65) and on the insulin-like growth factor (IGF) axis including molecules such as IGF-binding protein 2 (IGFII).
II. To correlate the above soluble biomarker measurements with clinical endpoints.
III. To examine the correlation between the soluble biomarkers.
IV. To examine the predictive relationship of immunohistochemical tumor biomarkers at baseline, i.e. phosphorylated ribosomal protein S6 kinase (pS6), p-protein kinase B (pAKT), p-mitogen-activated protein kinase 1 (ERK), p-mitogen-activated protein kinase kinase (pMEK), hypoxia-inducible factor 2, alpha subunit (HIF2a), phosphatase and tensin homolog gene (PTEN), signal transducer and activator of transcription 3 (acute-phase response factor) (STAT3) and tumor protein p53 (p53), as well as of mutational status, i.e. p53, phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) and PTEN, with efficacy endpoints (time to progression [TTP]).
- To determine if soluble apoptosis markers (M30/M65) correlate with proliferative markers at baseline (proliferation-related Ki-67 antigen [Ki67] and p53) in archival tumor samples.
VI. To examine the relationship of immunohistochemical and/or soluble biomarkers with subgroup classification namely, patients with hepatitis B virus (HBV), patients with hepatitis C virus (HCV) and patients with other etiologies.
VII. To explore potential biomarker differences within patient subgroups, namely, patients with HBV, patients with HCV and patients with other etiologies.
VIII. To determine the effect of KD018 on cytokine/chemokine levels including interleukin (IL)-2, IL-4, IL-5, IL-6, IL-10, monocyte chemotactic protein 1 (MCP-1), tumor necrosis factor (TNF)-alpha, interferon (IFN)-alpha, VEGF, FGF-basic (b), sargramostim (GM-CSF), filgrastim (G-CSF).
IX. To explore potential relationships between efficacy and Cmin of sorafenib after co-administration with KD018 and between occurrence of adverse events and C1h/C2h endpoints (efficacy, safety, pharmacokinetics [PK]).
OUTLINE: This is a phase I, dose-escalation study of Chinese herbal formulation PHY906.
Patients receive Chinese herbal formulation PHY906 orally (PO) twice daily (BID) on days 1-4, 8-11, 15-18, 21-24 and sorafenib tosylate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
- Conditions
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Advanced Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma
- Being tested
- Chinese herbal formulation PHY906, sorafenib tosylate, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal formulation PHY906Dietary supplement
Also called PHY-906, KD018
Given PO
sorafenib tosylateDrug
Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar
Given PO
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Chinese herbal formulation PHY906 and sorafenib) | Experimental | Patients receive Chinese herbal formulation PHY906 PO BID on days 1-4, 8-11, 15-18, 21-24 and sorafenib tosylate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: Chinese herbal formulation PHY906; Drug: sorafenib tosylate; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: 28 days
Secondary outcomes (6)
Adverse events as determined by NCI CTCAE version 4
Measured: Up to 4 weeks after completion of study treatment
Serious adverse events as determined by NCI CTCAE version 4
Measured: Up to 4 weeks after completion of study treatment
Discontinuation rate
Measured: Up to 6 years
Dose adjustment rate
Measured: Up to 6 years
Tumor response in terms of best overall response, assessed using RECIST
Measured: Up to 6 years
Sorafenib tosylate concentration after co-administration with Chinese herbal formulation PHY906
Measured: Baseline; 1 hour post-dose; 2 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study start11 Jun 2014
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Primary Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Chao, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666756
- Sponsor's protocol ID
- 11043
- Other IDs
- NCI-2012-01324, 5P01CA154295-02
- Status last verified
- Jan 2021
- First submitted
- 14 Aug 2012
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Study Investigating the Combination of KD018 and Sorafenib (Nexavar) in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01666756
- Acronym / sponsor ID
- 11043
- Conditions
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Advanced Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 16 Aug 2012 (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 studies the side effects and best dose of Chinese herbal formulation PHY906 when given together with sorafenib tosylate in treating patients with advanced liver cancer. Biological therapies, such as Chinese herbal formulation PHY906, may interfere with the growth of tumor cells and slow the growth of tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving Chinese herbal formulation PHY906 together with sorafenib tosylate may work better in treating advanced liver cancer.
Detailed description
PRIMARY OBJECTIVES:
- To characterize the safety and tolerability of KD018 (Chinese herbal formulation PHY906) in combination with daily sorafenib (sorafenib tosylate) and to determine the maximum tolerated dose (MTD) of the combination of KD018 plus sorafenib to bring forward into phase 2.
SECONDARY OBJECTIVES:
- To describe the efficacy of the combination of KD018 plus sorafenib at the explored dose-levels in terms of best overall response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
II. To assess the safety and tolerability of the combination of KD018 plus sorafenib as measured by the rate and severity of adverse events (AEs).
III. To determine the steady state of sorafenib after KD018 exposure at pre-dose and 1 hour and 2 hours post-dose at the explored combination dose-levels using concentrations at pre-dose (Cmin) and at 1 hour (C1h) and 2 hours (C2h) post-dose.
TERTIARY OBJECTIVES:
- To assess the effect of treatment on soluble markers of angiogenesis, fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), placental growth factor (PLGF), soluble vascular endothelial growth factor receptor 1 (sVEGFR1), sVEGFR2, apoptosis (i.e. M30 monoclonal antibody [M30] and M65) and on the insulin-like growth factor (IGF) axis including molecules such as IGF-binding protein 2 (IGFII).
II. To correlate the above soluble biomarker measurements with clinical endpoints.
III. To examine the correlation between the soluble biomarkers.
IV. To examine the predictive relationship of immunohistochemical tumor biomarkers at baseline, i.e. phosphorylated ribosomal protein S6 kinase (pS6), p-protein kinase B (pAKT), p-mitogen-activated protein kinase 1 (ERK), p-mitogen-activated protein kinase kinase (pMEK), hypoxia-inducible factor 2, alpha subunit (HIF2a), phosphatase and tensin homolog gene (PTEN), signal transducer and activator of transcription 3 (acute-phase response factor) (STAT3) and tumor protein p53 (p53), as well as of mutational status, i.e. p53, phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) and PTEN, with efficacy endpoints (time to progression [TTP]).
- To determine if soluble apoptosis markers (M30/M65) correlate with proliferative markers at baseline (proliferation-related Ki-67 antigen [Ki67] and p53) in archival tumor samples.
VI. To examine the relationship of immunohistochemical and/or soluble biomarkers with subgroup classification namely, patients with hepatitis B virus (HBV), patients with hepatitis C virus (HCV) and patients with other etiologies.
VII. To explore potential biomarker differences within patient subgroups, namely, patients with HBV, patients with HCV and patients with other etiologies.
VIII. To determine the effect of KD018 on cytokine/chemokine levels including interleukin (IL)-2, IL-4, IL-5, IL-6, IL-10, monocyte chemotactic protein 1 (MCP-1), tumor necrosis factor (TNF)-alpha, interferon (IFN)-alpha, VEGF, FGF-basic (b), sargramostim (GM-CSF), filgrastim (G-CSF).
IX. To explore potential relationships between efficacy and Cmin of sorafenib after co-administration with KD018 and between occurrence of adverse events and C1h/C2h endpoints (efficacy, safety, pharmacokinetics [PK]).
OUTLINE: This is a phase I, dose-escalation study of Chinese herbal formulation PHY906.
Patients receive Chinese herbal formulation PHY906 orally (PO) twice daily (BID) on days 1-4, 8-11, 15-18, 21-24 and sorafenib tosylate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Chinese herbal formulation PHY906 and sorafenib) | Experimental | Dietary Supplement: Chinese herbal formulation PHY906, Drug: sorafenib tosylate, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive Chinese herbal formulation PHY906 PO BID on days 1-4, 8-11, 15-18, 21-24 and sorafenib tosylate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability to take oral drugs
- Diagnosis of advanced hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) guidelines
- HCC stage B or C according to the Barcelona Clinic Liver Cancer (BCLC)
- Previous or current use of sorafenib allowed
- Measurable disease according to RECIST, i.e. at least one measurable lesion; this lesion should not have been previously treated with local therapy; a treated lesion may be used where these lesions are the only lesions available for evaluation and have shown definite progression since their last local treatment; local therapy must have been completed at least four weeks prior to baseline evaluation
Key exclusion criteria (16 listed)
- Patients currently receiving any anti-cancer therapy, except sorafenib, or who have received any local anti-cancer therapy =< 4 weeks prior to baseline computed tomography (CT)/magnetic resonance imaging (MRI) scan, prior to cycle 1 treatment
- Active bleeding during the last 30 days prior to cycle 1 treatment including variceal bleeding (esophageal varices should be treated according to standard practice e.g. ligation/banding and procedure completed 30 days prior to cycle 1 treatment)
- Patients with a known hypersensitivity to KD018 or known hypersensitivity to sorafenib or contraindications to sorafenib based on the local sorafenib label
- Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- Any severe and/or uncontrolled medical conditions including:
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 |
|---|---|---|
| Chinese herbal formulation PHY906Also: PHY-906, KD018Given PO | Dietary supplement | Treatment (Chinese herbal formulation PHY906 and sorafenib) |
| sorafenib tosylateAlso: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, NexavarGiven PO | Drug | Treatment (Chinese herbal formulation PHY906 and sorafenib) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (Chinese herbal formulation PHY906 and sorafenib) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (Chinese herbal formulation PHY906 and sorafenib) |
Primary outcome
Recommended phase II dose, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: 28 days
6 secondary outcomes
Adverse events as determined by NCI CTCAE version 4
Time frame: Up to 4 weeks after completion of study treatment
Serious adverse events as determined by NCI CTCAE version 4
Time frame: Up to 4 weeks after completion of study treatment
Discontinuation rate
Time frame: Up to 6 years
Dose adjustment rate
Time frame: Up to 6 years
Tumor response in terms of best overall response, assessed using RECIST
Time frame: Up to 6 years
Sorafenib tosylate concentration after co-administration with Chinese herbal formulation PHY906
Time frame: Baseline; 1 hour post-dose; 2 hours post-dose
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 27 Jan 2021.
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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.
Joseph Chao, MD principal investigator
City of Hope Medical Center
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 Chinese herbal formulation PHY906, sorafenib tosylate and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by City of Hope Medical Center 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 18 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 27 Jan 2021. 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?
Recommended phase II dose, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 (time frame: 28 days). 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 27 Jan 2021.