Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01642342
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
A Phase 1 study testing laboratory biomarker analysis, pharmacological study and recombinant albumin fusion protein sEphB4-HSA in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California at 1 site in United States.
Trial summary
This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. 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?
- laboratory biomarker analysis, pharmacological study and recombinant albumin fusion protein sEphB4-HSA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2012to 29 May 2019
- 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
- For expansion Cohort A: Advanced (metastatic or recurrent) pathologically proven solid tumor which has not responded to standard therapy or which has progressed following standard therapy for advanced disease and/or for which no standard therapy is known to be effective. Measurable disease required.
- For expansion Cohort B: Advanced pathologically proven mutant KRAS non-small cell lung cancer (group 1), pancreatic cancer (group 2; documentation of KRAS mutation not required), mutant KRAS colorectal cancer (group 3), head and neck squamous cell carcinoma (group 4) mesothelioma (group 5), hepatocellular cancer (group 6), and biliary carcinoma (group 7). Measurable disease required.
- Must agree, as part of the informed consent, to provide blood and tumor samples for molecular correlates, pharmacokinetics and pharmacodynamics. Patients in expansion cohort A must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy. Patients in cohort B group 3 \& 4 must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Life expectancy of at least 12 weeks
- Patients or their legal representatives must be able to comprehend and provide written informed consent
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- White blood count (WBC) >= 3,000/μl
- Absolute neutrophil count (ANC) >= 1,500/μl
- Platelet count >= 100,000/μl (except in hepatocellular carcinoma patients with portal hypertension for whom a platelet count of >= 70,000/μl is allowed)
- Serum creatinine =< 1.5 X upper limit of normal (ULN) for reference lab
- Creatinine Clearance of >= 60 (as calculated by Cockcroft-Gault formula
- Serum bilirubin =< 1.5 mg/dL
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =< 3X the ULN for the reference lab (=< 5X the ULN if there is evidence of hepatic involvement by malignant disease)
- Recovered to grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
- WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of study drug
- Patients with hepatitis B infection must be on appropriate antiviral therapy
- For cohort B, group 1: Non-small cell lung cancer:
- Must have advanced non-small cell lung cancer with mutant KRAS
- Must have failed a minimum of one previous line of chemotherapy for advanced disease
- For cohort B, group 2: Pancreatic cancer:
- Must have failed a minimum of one previous line of therapy for advanced disease
- For cohort B, group 3: Colorectal cancer:
- Must have colorectal adenocarcinoma that harbor a KRAS mutation
- Must have failed a minimum of one previous line of chemotherapy
- For cohort B, group 4: Head and neck squamous cell cancer:
- Must have failed a platinum based chemotherapy regimen that was administered for advanced disease with a palliative intent; patients treated with concurrent platinum agent and radiation as definitive therapy are not eligible unless they subsequently received another line of systemic therapy.
- For cohort B, group 5: Mesothelioma:
- Must have histologically or cytologically proven diagnosis of malignant mesothelioma; both pleural and peritoneal mesothelioma are allowed
- Must have failed a minimum of one previous line of systemic therapy for advanced disease
- For cohort B, group 6: Hepatocellular carcinoma:
- Patients with hepatocellular carcinoma do not need to have histologic confirmation of disease as long as they meet the radiologic criteria for diagnosis of HCC (evidence of arterial phase enhancement with corresponding venous or delayed phase wash out).
- Must have advanced disease that is not amenable for resection or transplantation, and that is not treatable with liver directed modalities such as radiofrequency ablation or transarterial chemoembolization
- Patients are not required to have failed Sorafenib
- For cohort B, group 7: Gallbladder cancer or cholangiocarcinoma:
- Must have failed a minimum of one previous line of systemic therapy for advanced disease. If patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other.
Who cannot join
- Undergoing or have undergone in the past 28 days any other therapy for their cancer, including radiation and adjuvant therapy
- Major systemic infection requiring antibiotics 72 hours or less prior to first dose of study drug
- Untreated central nervous system (CNS) metastases; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial
- Have New York Heart Association (NYHA) class 3 or 4, myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or places the patient at undue risk for treatment related complications
- Any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
- Pregnant or lactating
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- On any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
- Any active bleeding in the last =< 4 weeks or have an otherwise known bleeding diathesis
- QTcF (Fridericia Correction Formula) > 480 on 2 out of 3 EKG's (if first EKG is < 480, no need to repeat, if first EKG is > 480 repeat twice for a total of 3 EKG's)
- For cohort B, group 1: Non-small cell lung cancer:
- Must not have clinically significant active hemoptysis
- For cohort B, group 4: Head and neck squamous cell cancer:
- Must not have evidence of major vessel involvement or encasement by tumor
- For cohort B, group 6: Hepatocellular Carcinoma:
- Child Pugh score > 7
- Ascites that is not medically controlled or that required a therapeutic paracentesis within last 3 months
- Any episode of hepatic encephalopathy within the previous 6 months
- Variceal bleeding within last 6 months
- Patients with evidence of portal hypertension must have had an EGD within last year with appropriate treatment of esophageal varices as per standard of care
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A First-In-Human Phase I Study of sEphB4-HSA in Patients With Advanced Solid Tumors With Expansion at the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D).
This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of sEphB4-HSA.
II. To describe the dose limiting toxicities and adverse event profile of sEphB4-HSA in patients with advanced solid tumors.
III. To describe the pharmacokinetics of sEphB4-HSA. IV. To describe the anti-tumor activity of sEphB4-HSA as manifested by responses to treatment.
- To obtain preliminary evaluation of effect of sEphB4-HSA on absolute circulating tumor cell (CTC) numbers as compared with pre-treatment levels using pre- and during treatment CTC. Exploratory evaluation of effect of sEphB4-HSA on downstream protein mediators of the Ephrin pathway (pAKT, pSrc) and their transcriptional target genes (rgs5 and psenen) will be performed.
VI. To collect pilot information to identify a dose or doses with biologic activity. Biologic activity after treatment with sEphB4-HSA will be defined as evidence of drug-on-target effect as manifested by reduction in absolute CTC numbers. Other exploratory evaluations of drug-on-target effect such as increase in transcript levels of psenen or rgs5 may be considered in the assessment of biologic activity.
OUTLINE: This is a dose-escalation study. Patients will be assigned to receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes in one of the following treatment schedules:
- Weekly treatment - administered on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Every 2 weeks treatment - administered on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Every 3 weeks treatment - administered on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Being tested
- laboratory biomarker analysis, pharmacological study, recombinant albumin fusion protein sEphB4-HSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
recombinant albumin fusion protein sEphB4-HSABiological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Weekly Treatment (sEphB4-HSA) | Experimental | Patients receive recombinant albumin fusion protein sEphB4-HSA IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: laboratory biomarker analysis; Other: pharmacological study; Biological: recombinant albumin fusion protein sEphB4-HSA |
| Every 2 Weeks Treatment (sEphB4-HSA) | Experimental | Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: laboratory biomarker analysis; Other: pharmacological study; Biological: recombinant albumin fusion protein sEphB4-HSA |
| Every 3 Weeks Treatment (sEphB4-HSA) | Experimental | Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Other: laboratory biomarker analysis; Other: pharmacological study; Biological: recombinant albumin fusion protein sEphB4-HSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities observed at each dose level utilizing the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize toxicities and side effects by dose and by course.
Measured: At least 4 weeks after the start of the first course
Number of patients with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or inevaluable (IE)
Summarized by dose level in the dose escalation and in the expansion cohort.
Measured: Up to 2 years
Survival
Summarized with Kaplan-Meier plots to describe the outcome.
Measured: Up to 2 years
Time to failure
Summarized with Kaplan-Meier plots to describe the outcome.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start6 Sep 2012
- Primary completion29 May 2019
- Study completion29 May 2019
Why it stopped: Lack of funding
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.
- More trials run by University of Southern CaliforniaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vasgene Therapeutics, Inc, The V Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Anthony El-Khoueiry, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642342
- Sponsor's protocol ID
- 0C-11-3
- Other IDs
- NCI-2012-00971
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2012
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Phase I Study of sEphB4-HSA in Patients With Advanced Solid Tumors With Expansion at the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D).
- ClinicalTrials.gov ID
- NCT01642342
- Acronym / sponsor ID
- 0C-11-3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vasgene Therapeutics, Inc, The V Foundation for Cancer Research
- Study start
- 6 Sep 2012 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 17 Jul 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 study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice
Detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of sEphB4-HSA.
II. To describe the dose limiting toxicities and adverse event profile of sEphB4-HSA in patients with advanced solid tumors.
III. To describe the pharmacokinetics of sEphB4-HSA. IV. To describe the anti-tumor activity of sEphB4-HSA as manifested by responses to treatment.
- To obtain preliminary evaluation of effect of sEphB4-HSA on absolute circulating tumor cell (CTC) numbers as compared with pre-treatment levels using pre- and during treatment CTC. Exploratory evaluation of effect of sEphB4-HSA on downstream protein mediators of the Ephrin pathway (pAKT, pSrc) and their transcriptional target genes (rgs5 and psenen) will be performed.
VI. To collect pilot information to identify a dose or doses with biologic activity. Biologic activity after treatment with sEphB4-HSA will be defined as evidence of drug-on-target effect as manifested by reduction in absolute CTC numbers. Other exploratory evaluations of drug-on-target effect such as increase in transcript levels of psenen or rgs5 may be considered in the assessment of biologic activity.
OUTLINE: This is a dose-escalation study. Patients will be assigned to receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes in one of the following treatment schedules:
- Weekly treatment - administered on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Every 2 weeks treatment - administered on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Every 3 weeks treatment - administered on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weekly Treatment (sEphB4-HSA) | Experimental | Other: laboratory biomarker analysis, Other: pharmacological study, Biological: recombinant albumin fusion protein sEphB4-HSAPatients receive recombinant albumin fusion protein sEphB4-HSA IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Every 2 Weeks Treatment (sEphB4-HSA) | Experimental | Other: laboratory biomarker analysis, Other: pharmacological study, Biological: recombinant albumin fusion protein sEphB4-HSAPatients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Every 3 Weeks Treatment (sEphB4-HSA) | Experimental | Other: laboratory biomarker analysis, Other: pharmacological study, Biological: recombinant albumin fusion protein sEphB4-HSAPatients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1. Courses repeat every 21 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 (36 listed)
- For expansion Cohort A: Advanced (metastatic or recurrent) pathologically proven solid tumor which has not responded to standard therapy or which has progressed following standard therapy for advanced disease and/or for which no standard therapy is known to be effective. Measurable disease required.
- For expansion Cohort B: Advanced pathologically proven mutant KRAS non-small cell lung cancer (group 1), pancreatic cancer (group 2; documentation of KRAS mutation not required), mutant KRAS colorectal cancer (group 3), head and neck squamous cell carcinoma (group 4) mesothelioma (group 5), hepatocellular cancer (group 6), and biliary carcinoma (group 7). Measurable disease required.
- Must agree, as part of the informed consent, to provide blood and tumor samples for molecular correlates, pharmacokinetics and pharmacodynamics. Patients in expansion cohort A must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy. Patients in cohort B group 3 \& 4 must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Life expectancy of at least 12 weeks
Key exclusion criteria (19 listed)
- Undergoing or have undergone in the past 28 days any other therapy for their cancer, including radiation and adjuvant therapy
- Major systemic infection requiring antibiotics 72 hours or less prior to first dose of study drug
- Untreated central nervous system (CNS) metastases; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial
- Have New York Heart Association (NYHA) class 3 or 4, myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or places the patient at undue risk for treatment related complications
- Any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Every 2 Weeks Treatment (sEphB4-HSA), Every 3 Weeks Treatment (sEphB4-HSA), Weekly Treatment (sEphB4-HSA) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Every 2 Weeks Treatment (sEphB4-HSA), Every 3 Weeks Treatment (sEphB4-HSA), Weekly Treatment (sEphB4-HSA) |
| recombinant albumin fusion protein sEphB4-HSAGiven IV | Biological | Every 2 Weeks Treatment (sEphB4-HSA), Every 3 Weeks Treatment (sEphB4-HSA), Weekly Treatment (sEphB4-HSA) |
Primary outcome
Toxicities observed at each dose level utilizing the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Time frame: At least 4 weeks after the start of the first course
Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize toxicities and side effects by dose and by course.
Number of patients with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or inevaluable (IE)
Time frame: Up to 2 years
Summarized by dose level in the dose escalation and in the expansion cohort.
Survival
Time frame: Up to 2 years
Summarized with Kaplan-Meier plots to describe the outcome.
Time to failure
Time frame: Up to 2 years
Summarized with Kaplan-Meier plots to describe the outcome.
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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 El-Khoueiry principal investigator
University of Southern California
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 laboratory biomarker analysis, pharmacological study and recombinant albumin fusion protein sEphB4-HSA in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California 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 36 inclusion and 19 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: stopped early, as of the sponsor's last update on 24 Aug 2022. 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Toxicities observed at each dose level utilizing the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 (time frame: At least 4 weeks after the start of the first course). The study lists 4 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 24 Aug 2022.