Lung NeoplasmsPhase 2NCT02839681
Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma
A Phase 2 study testing Anetumab Ravtansine and Blood test in people with Lung Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a protein on the surface of tumor cells in many types of tumors, including most lung cancers. Researchers want to find a safe dose for the study drug for lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Anetumab Ravtansine and Blood test
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2016to 25 Jul 2018
- Phase
- Phase 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from lung adenocarcinoma, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated <2 years before the start of study treatment.
- Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage/bleeding event of Common Terminology Criteria in Adverse Events (CTCAE) Grade greater than or equal to 2 within 4 weeks before the start of study treatment.
- History of symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy and has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry. Subjects with brain metastases must not be undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for one month prior to screening.
- Subjects who have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:
- Congestive heart failure of New York Heart Association (NYHA) Class III or IV
- Unstable angina (symptoms of angina at rest) or new-onset angina within <3 months before the start of study treatment.
Show all 32Show fewer
- Arterial thrombosis, deep vein thrombosis, or pulmonary embolism within <3 months before the start of study treatment.
- Myocardial infarction or stroke within <3 months before the start of study treatment.
- Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade greater than or equal to 2) or pleural effusion (CTCAE Grade greater than or equal to 2)
- Cardiac arrhythmia requiring anti-arrhythmic therapy. Subjects receiving digoxin, calcium channel blockers except verapamil, or beta-adrenergic blockers except propranolol are eligible at the investigators discretion if the dose has been stable for at least 2 weeks before the start of study treatment. Subjects with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigators discretion.
- Subjects who have a left ventricular ejection fraction (LVEF) <50%, as assessed by echocardiogram performed at screening.
- Subjects who have a corrected Q wave, T wave (QT) (corrected QT interval by Fredericia (QTcF)) interval >480 ms (CTCAE Grade >1) determined by the electrocardiogram (ECG) recorders algorithm on the screening ECG.
- Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg at screening despite optimal medical management. Subjects with a history of mild to moderate
- hypertension are eligible at the investigator s discretion if the hypertension is adequately controlled by antihypertensive treatment used at a stable dose for at least 2 weeks before the start of study treatment.
- Subjects who have a heart rate greater than or equal to 100 beats per minute (bpm) or less than or equal to 45 bpm determined by the ECG recorder s algorithm on the screening ECG.
- Women who are pregnant or breast-feeding. Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test obtained within 7 days before the start of study treatment.
- Subjects who have had a major surgery or significant trauma within 4 weeks before the start of study treatment.
- Subjects who have had solid organ or bone marrow transplantation.
- Subjects who have a history of hypersensitivity to any of the study drugs or their excipients, or a history of severe hypersensitivity to any other antigen.
- Subjects who have a history of human immunodeficiency virus (HIV) infection or subjects who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment due to a theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection. Subjects with chronic HBV or HCV infection are eligible at the investigators discretion if the subject is considered non-infectious based on serological markers.
- Subjects who have an active clinically serious infection of CTCAE Grade greater than or equal to 2.
- Subjects with a non-healing serious wound, ulcer, or bone fracture unrelated to the primary tumor.
- Subjects with corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the discretion of the investigator in consultation with the ophthalmologist/optometrist. Low grades of superficial punctate keratitis, within the range seen in the normal population, should not lead to the exclusion of the patient
- Subjects experiencing unresolved toxicity of previous antitumor therapy which is CTCAE Grade >1 before the start of study treatment, except for alopecia or hemoglobin greater than or equal to 9.0 g/dL or greater than or equal to 5.6 mmol/L.
- Subjects with any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subjects compliance in the study.
- Subjects who have received systemic anticancer therapy within 3 weeks before the start of study treatment. Mitomycin C or nitrosoureas must be excluded within 6 weeks before the start of study treatment.
- Subjects who have received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, except if there is objective evidence of progression of the lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the
- prior radiotherapy and the screening computed tomography (CT) or magnetic resonance imaging (MRI) scan. Palliative radiotherapy to nontarget lesions is allowed at the investigators discretion.
- Use of drugs that inhibit renal tubular secretion (e.g. probenecid and cimetidine) within 2 weeks before the start of study treatment.
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the start of study treatment.
- Subjects who have previously received anetumab ravtansine.
- Subjects who are concurrently receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial With Safety Run-in of the Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma
Background:
Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a protein on the surface of tumor cells in many types of tumors, including most lung cancers. Researchers want to find a safe dose for the study drug for lung cancer. They want to see if it can shrink tumors in mesothelin-positive lung cancer.
Read more
Objectives:
To test the safety and effectiveness of anetumab ravtansine for lung cancer.
Eligibility:
Adults 18 years and older who have lung cancer that has gotten worse on other therapy
Design:
Participants will be screened with:
Medical history
Physical exam
Tumor tissue sample. This can be from a previous procedure.
Blood and urine tests
Heart tests
Scans. For one scan, a small amount of radioactive substance is injected into the blood.
Eye exam
The study will have 21-day cycles.
On day 1 of each cycle, participants will get the study drug through a tube inserted in a vein.
Participants will repeat a heart test in cycles 1 and 2.
They will have blood tests weekly in cycle 1, twice in all other cycles.
They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of year 2, then every 12 weeks.
Participants will have samples of tumor tissue taken twice.
About 30 days after stopping the study drug, participants will have a follow-up visit. This will include medical history, physical exam, blood and pregnancy tests, and heart and eye tests.
Some will be called a few times a year to discuss their health and treatment.
Read the detailed description
Background:
- Lung cancer is the leading cause of cancer-related death worldwide, accounting for more than one million deaths every year.
- Non-small-cell lung cancer (NSCLC) constitutes approximately 85% of lung cancers and about 40% of patients with newly diagnosed NSCLC have advanced disease. The median year overall survival for advanced NSCLC is at least 1 year.
- In recent years, identification of oncogenic alterations such as mutations in epidermal growth factor receptor (EGFR) and anaplastic large-cell lymphoma kinase (ALK) translocations and therapies targeting tumor immune escape mechanisms have led to a substantial improvement in the prognosis of patients with advanced lung cancer; however, such alterations have been detected in less than half of all advanced NSCLC patients in only a small subset of patients respond to immunotherapeutic interventions available today.
- Anetumab ravtansine (BAY 94-9343) is an antibody-drug conjugate targeting mesothelin, a protein normally present on mesothelial cells. A Phase I trial showed the overall acceptable and manageable safety profile. It is being developed for patients with mesothelin expressing cancers; clinical development is furthest along in mesothelioma where it is in a registration phase II clinical trial.
- National Cancer Institute (NCI) researchers have demonstrated that mesothelin messenger ribonucleic acid (mRNA) and protein are present in a substantial number of lung adenocarcinoma cell lines; mesothelin expression has been observed in over 50% of advanced lung adenocarcinomas by immunohistochemical assessment.
Objectives:
Safety Run-in
-To evaluate safety and tolerability of anetumab ravtansine in patients with previously treated unresectable mesothelin expressing advanced lung adenocarcinoma (stage IIIB or IV).
Phase 2
-To determine the efficacy (objective response rate) of anetumab ravtansine in patients with advanced (Stage IIIb) or metastatic (Stage IV) mesothelin expressing lung adenocarcinoma.
Eligibility:
- Age >18 years.
- Histologically or cytologically confirmed previously treated unresectable mesothelin expressing advanced lung adenocarcinoma (stage IIIB or IV)
- Positive mesothelin expression in the archival tumor tissue, defined as the mesothelin membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on the membrane of greater than or equal to 10% of tumor cells.
- Should have received at least one prior platinum based chemotherapy and an immune checkpoint targeted agent. In addition, subjects with epidermal growth factor receptor [EGFR]-mutated and anaplastic lymphoma kinase [ALK]-translocated NSCLC should have received Food and Drug Administration (FDA)-approved targeted therapies as appropriate.
- Normal organ function
Design:
- This is an open label, single center, phase I/II study of anetumab ravtansine in subjects with mesothelin positive lung adenocarcinoma.
- During the safety run-in portion of the study, de-escalating doses will be assessed to determine a recommended phase 2 dose (RP2D).
- During the phase 2 portion of the study, the (RP2D) will be assessed for objective response rate.
- During both portions of the study, anetumab ravtansine will be administered intravenously every 3 weeks until disease progression in the absence of clinical benefit, patient withdrawal or the occurrence of intolerable toxicities.
- Response assessments (imaging) will occur every 6 weeks for the first 6 months, then every 9 weeks until the end of year 2, then every 12 weeks thereafter.
- Up to 12 evaluable patients will be enrolled in the safety run-in portion of the study. Approximately twenty patients, including 6 from the safety run-in portion of the study, will be evaluated in the phase 2 portion of the study. The accrual ceiling will be set at 55 to accommodate screen failures (a 50% failure rate with regard to mesothelin expression) and inevaluable subjects.
- Conditions
- Lung Neoplasms
- Being tested
- Anetumab Ravtansine, Blood test
- Keywords
- Lung Adenocarcinoma, Immunotoxin, Immunotherapy
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anetumab RavtansineDrug
Also called BAY 94-9343
Administered intravenously (IV) every 3 weeks
Blood testDevice
Research blood test for eligibility
| Study group | Role | What they receive |
|---|---|---|
| 1/Safety Run-in Arm | Experimental | Subjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study Receives: Drug: Anetumab Ravtansine; Device: Blood test |
| 2/Phase 2 Arm | Experimental | Subjects will be dosed with anetumab ravtansine at the recommended phase 2 dose (dose level 1 if no more than 1 dose limiting toxicity (DLT) occurred in the safety run-in arm, or at dose level -1 otherwise) Receives: Drug: Anetumab Ravtansine; Device: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
The highest dose tested at which no more than 1 dose limiting toxicity occurs. A dose limiting toxicity is defined as any treatment emergent adverse event (TEAE) (i.e., absolute neutrophil count <500/mm^3 for ≥7 days) occurring during Cycle 1 and regarded to be at least possibly related to anetumab ravtansine.
Measured: 21 days after initiation of study therapy
Proportion of Subjects Who Experienced a Partial or Complete Response
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). A complete response is disappearance of all target lesions. A partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: 6 weeks
Secondary outcomes (4)
Progression Free Survival
Length of time from start of treatment to time of progression or death, whichever occurs first. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Measured: At Disease Progression, approximately 6 weeks.
Duration of Response
Duration of Response is from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR). Length of time criteria are met for partial response or complete response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). A complete response is disappearance of all target lesions. A partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: At Disease Progression, approximately 6 weeks from start of treatment
Overall Survival
Length of time from start of treatment to death from any cause.
Measured: At Death, an average of 7.5 weeks after start of first cycle for both patients.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Participants on the Safety run-in phase was assessed for approximately two months and 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start19 Jul 2016
- Primary completion12 Jun 2018
- Study completion25 Jul 2018
Why it stopped: Due to slow, insufficient accrual.
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.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Raffit Hassan, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Raffit Hassan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839681
- Sponsor's protocol ID
- 160145
- Other IDs
- 16-C-0145
- Status last verified
- Apr 2019
- First submitted
- 19 Jul 2016
- Last updated
- 21 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial With Safety Run-in of the Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02839681
- Acronym / sponsor ID
- 160145
- Conditions
- Lung Neoplasms
- Keywords
- Lung Adenocarcinoma, Immunotoxin, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow, insufficient accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 21 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a protein on the surface of tumor cells in many types of tumors, including most lung cancers. Researchers want to find a safe dose for the study drug for lung cancer. They want to see if it can shrink tumors in mesothelin-positive lung cancer.
Objectives:
To test the safety and effectiveness of anetumab ravtansine for lung cancer.
Eligibility:
Adults 18 years and older who have lung cancer that has gotten worse on other therapy
Design:
Participants will be screened with:
Medical history
Physical exam
Tumor tissue sample. This can be from a previous procedure.
Blood and urine tests
Heart tests
Scans. For one scan, a small amount of radioactive substance is injected into the blood.
Eye exam
The study will have 21-day cycles.
On day 1 of each cycle, participants will get the study drug through a tube inserted in a vein.
Participants will repeat a heart test in cycles 1 and 2.
They will have blood tests weekly in cycle 1, twice in all other cycles.
They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of year 2, then every 12 weeks.
Participants will have samples of tumor tissue taken twice.
About 30 days after stopping the study drug, participants will have a follow-up visit. This will include medical history, physical exam, blood and pregnancy tests, and heart and eye tests.
Some will be called a few times a year to discuss their health and treatment.
Detailed description
Background:
- Lung cancer is the leading cause of cancer-related death worldwide, accounting for more than one million deaths every year.
- Non-small-cell lung cancer (NSCLC) constitutes approximately 85% of lung cancers and about 40% of patients with newly diagnosed NSCLC have advanced disease. The median year overall survival for advanced NSCLC is at least 1 year.
- In recent years, identification of oncogenic alterations such as mutations in epidermal growth factor receptor (EGFR) and anaplastic large-cell lymphoma kinase (ALK) translocations and therapies targeting tumor immune escape mechanisms have led to a substantial improvement in the prognosis of patients with advanced lung cancer; however, such alterations have been detected in less than half of all advanced NSCLC patients in only a small subset of patients respond to immunotherapeutic interventions available today.
- Anetumab ravtansine (BAY 94-9343) is an antibody-drug conjugate targeting mesothelin, a protein normally present on mesothelial cells. A Phase I trial showed the overall acceptable and manageable safety profile. It is being developed for patients with mesothelin expressing cancers; clinical development is furthest along in mesothelioma where it is in a registration phase II clinical trial.
- National Cancer Institute (NCI) researchers have demonstrated that mesothelin messenger ribonucleic acid (mRNA) and protein are present in a substantial number of lung adenocarcinoma cell lines; mesothelin expression has been observed in over 50% of advanced lung adenocarcinomas by immunohistochemical assessment.
Objectives:
Safety Run-in
-To evaluate safety and tolerability of anetumab ravtansine in patients with previously treated unresectable mesothelin expressing advanced lung adenocarcinoma (stage IIIB or IV).
Phase 2
-To determine the efficacy (objective response rate) of anetumab ravtansine in patients with advanced (Stage IIIb) or metastatic (Stage IV) mesothelin expressing lung adenocarcinoma.
Eligibility:
- Age >18 years.
- Histologically or cytologically confirmed previously treated unresectable mesothelin expressing advanced lung adenocarcinoma (stage IIIB or IV)
- Positive mesothelin expression in the archival tumor tissue, defined as the mesothelin membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on the membrane of greater than or equal to 10% of tumor cells.
- Should have received at least one prior platinum based chemotherapy and an immune checkpoint targeted agent. In addition, subjects with epidermal growth factor receptor [EGFR]-mutated and anaplastic lymphoma kinase [ALK]-translocated NSCLC should have received Food and Drug Administration (FDA)-approved targeted therapies as appropriate.
- Normal organ function
Design:
- This is an open label, single center, phase I/II study of anetumab ravtansine in subjects with mesothelin positive lung adenocarcinoma.
- During the safety run-in portion of the study, de-escalating doses will be assessed to determine a recommended phase 2 dose (RP2D).
- During the phase 2 portion of the study, the (RP2D) will be assessed for objective response rate.
- During both portions of the study, anetumab ravtansine will be administered intravenously every 3 weeks until disease progression in the absence of clinical benefit, patient withdrawal or the occurrence of intolerable toxicities.
- Response assessments (imaging) will occur every 6 weeks for the first 6 months, then every 9 weeks until the end of year 2, then every 12 weeks thereafter.
- Up to 12 evaluable patients will be enrolled in the safety run-in portion of the study. Approximately twenty patients, including 6 from the safety run-in portion of the study, will be evaluated in the phase 2 portion of the study. The accrual ceiling will be set at 55 to accommodate screen failures (a 50% failure rate with regard to mesothelin expression) and inevaluable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Safety Run-in Arm | Experimental | Drug: Anetumab Ravtansine, Device: Blood testSubjects will be dosed with the higher of the 2 possible anetumab ravtansine doses (dose level 1) evaluated on the study |
| 2/Phase 2 Arm | Experimental | Drug: Anetumab Ravtansine, Device: Blood testSubjects will be dosed with anetumab ravtansine at the recommended phase 2 dose (dose level 1 if no more than 1 dose limiting toxicity (DLT) occurred in the safety run-in arm, or at dose level -1 otherwise) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from lung adenocarcinoma, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated <2 years before the start of study treatment.
- Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage/bleeding event of Common Terminology Criteria in Adverse Events (CTCAE) Grade greater than or equal to 2 within 4 weeks before the start of study treatment.
- History of symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy and has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry. Subjects with brain metastases must not be undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for one month prior to screening.
- Subjects who have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:
- Congestive heart failure of New York Heart Association (NYHA) Class III or IV
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 |
|---|---|---|
| Anetumab RavtansineAlso: BAY 94-9343Administered intravenously (IV) every 3 weeks | Drug | 1/Safety Run-in Arm, 2/Phase 2 Arm |
| Blood testResearch blood test for eligibility | Device | 1/Safety Run-in Arm, 2/Phase 2 Arm |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: 21 days after initiation of study therapy
The highest dose tested at which no more than 1 dose limiting toxicity occurs. A dose limiting toxicity is defined as any treatment emergent adverse event (TEAE) (i.e., absolute neutrophil count <500/mm^3 for ≥7 days) occurring during Cycle 1 and regarded to be at least possibly related to anetumab ravtansine.
Proportion of Subjects Who Experienced a Partial or Complete Response
Time frame: 6 weeks
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). A complete response is disappearance of all target lesions. A partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
4 secondary outcomes
Progression Free Survival
Time frame: At Disease Progression, approximately 6 weeks.
Duration of Response
Time frame: At Disease Progression, approximately 6 weeks from start of treatment
Overall Survival
Time frame: At Death, an average of 7.5 weeks after start of first cycle for both patients.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Time frame: Participants on the Safety run-in phase was assessed for approximately two months and 5 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Raffit Hassan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anetumab Ravtansine and Blood test in people with Lung Neoplasms, run by National Cancer Institute (NCI) 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 0 inclusion and 32 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 21 May 2019. 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 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 21 May 2019). 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?
Recommended Phase 2 Dose (RP2D) (time frame: 21 days after initiation of study therapy). 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 21 May 2019.