MelanomaPhase 2NCT01200342
Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma
A Phase 2 study testing Genasense, Paclitaxel and Carboplatin in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Genasense, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a history of uveal melanoma and documented metastatic disease
- Patients must have at least one measurable lesion as per revised RECIST Criteria. A measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT slice is </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not considered measurable.
- Patients may be previously untreated or may have received prior systemic therapy but no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for metastatic disease.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting GCP therapy.
- At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.
- Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
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- Patients must have ECOG performance status of 0 - 2.
- Patients should be 18 years of age or older.
- Patients must have adequate liver and renal function as defined by total bilirubin </=1.5 mg/dl, serum Lactate Dehydrogenase level no higher than 2.0 x UNL of the institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum creatinine </=1.5 mg/dl or estimated Creatinine Clearance >/=60 ml/min
- Patients must have adequate bone marrow function as defined by an absolute neutrophil count of greater or equal to 1,500/mm3, and platelet count of greater or equal to 100,000/mm3.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
- Females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
Who cannot join
- Patients who have received prior therapy with Genasense, any taxane or any of cisplatin analogues for systemic disease.
- Patients whose site of primary melanoma is not in the choroid.
- Patients who have a current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate or cervix or other cancers treated for cure and with a disease-free survival longer than 2 years.
- Patients with brain metastasis or history of brain metastasis (es).
- Patients who are pregnant or breastfeeding.
- Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
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- Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
- Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. PI or his designee shall make the final determination regarding appropriateness of enrollment.
- Patients with a known hypersensitivity to cremophor containing anti-cancer agents.
- Patients with one or more of the following as the only manifestations of disease are ineligible: Osteoblastic bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
- Patients with Gilbert's Syndrome.
- Patients must not have had major surgery within the past 14 days.
- Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
- Known HIV disease or infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Genasense-Carboplatin-Paclitaxel-Combination in Uveal Melanoma
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
Read the detailed description
Study Drugs:
Oblimersen is designed to stop the body from making a protein that makes melanoma cells resistant to chemotherapy drugs. This may make carboplatin and/or paclitaxel more effective.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive oblimersen by vein over about 1 hour (+/- 5 minutes) on Days 1, 3, and 5 of each 21-day study "cycle." You will receive dexamethasone by vein over about 30 minutes before you receive oblimersen to help prevent side effects. You will take ibuprofen by mouth about 30 minutes before you receive oblimersen.
You will receive paclitaxel by vein over about 3 hours (+/- 5 minutes) on Day 3 of each cycle.
You will receive carboplatin by vein over about 30 minutes (+/- 5 minutes) on Day 3 of each cycle.
Before you receive each of these drugs, you may receive other drugs to help prevent side effects (such as nausea, vomiting, fever, and/or body aches). You may need to receive some of these drugs for some time after you receive the study drugs. Your doctor will tell you more about each of these drugs, about how they are given, and about any possible risks of receiving them.
Study Visits:
Within 3 days before each cycle, blood (about 1 tablespoon) will be drawn for routine tests.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
- Women who are able to become pregnant will have a routine urine pregnancy test done.
Each week while you are on study, blood (about 1 teaspoon) will be drawn for routine tests.
Every 6 weeks, you will have the same imaging (CT and/or MRI) scans that you had at screening to check the status of the disease. If the doctor thinks it is needed, you will have a bone scan.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit:
After you stop receiving the study drugs, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will be asked about any side effects you may have had.
- You will have the same imaging (CTand /or MRI) scans that you had at screening to check the status of the disease.
- Women who are able to become pregnant will have a routine urine pregnancy test done.
Follow-up:
Every 3 months for up to 2 years after you stop receiving the study drugs, you will be called and asked about how you are doing and about any other drugs you may be receiving. Each call will last about 3 minutes.
This is an investigational study. Carboplatin and paclitaxel are FDA approved and commercially available for the treatment of a variety of cancers including breast, lung, and ovarian cancers. Oblimersen is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Melanoma
- Being tested
- Genasense, Paclitaxel, Carboplatin
- Keywords
- Uveal melanoma, Carboplatin, Genasense, Paclitaxel, oblimersen, GCP
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenasenseDrug
Also called G3139, Oblimersen
900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle.
PaclitaxelDrug
Also called Taxol
175 mg/m^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense.
CarboplatinDrug
Also called Paraplatin
Carboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks.
The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC).
| Study group | Role | What they receive |
|---|---|---|
| Genasense + Paclitaxel + Carboplatin | Experimental | Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. Receives: Drug: Genasense; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Measured: Following two 3-week cycles
Number of Participants With Response
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Measured: Following two 3-week cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Pharmaceutical company no longer manufacturing investigational product.
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 MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genta Incorporated
- Responsible party
- Sponsor
- Investigators
- Sapna P. Patel, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200342
- Sponsor's protocol ID
- 2010-0188
- Status last verified
- Jan 2016
- First submitted
- 9 Sep 2010
- Last updated
- 11 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Genasense-Carboplatin-Paclitaxel-Combination in Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01200342
- Acronym / sponsor ID
- 2010-0188
- Conditions
- Melanoma
- Keywords
- Uveal melanoma, Carboplatin, Genasense, Paclitaxel, oblimersen, GCP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical company no longer manufacturing investigational product.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genta Incorporated
- Study start
- Dec 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 11 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
Detailed description
Study Drugs:
Oblimersen is designed to stop the body from making a protein that makes melanoma cells resistant to chemotherapy drugs. This may make carboplatin and/or paclitaxel more effective.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive oblimersen by vein over about 1 hour (+/- 5 minutes) on Days 1, 3, and 5 of each 21-day study "cycle." You will receive dexamethasone by vein over about 30 minutes before you receive oblimersen to help prevent side effects. You will take ibuprofen by mouth about 30 minutes before you receive oblimersen.
You will receive paclitaxel by vein over about 3 hours (+/- 5 minutes) on Day 3 of each cycle.
You will receive carboplatin by vein over about 30 minutes (+/- 5 minutes) on Day 3 of each cycle.
Before you receive each of these drugs, you may receive other drugs to help prevent side effects (such as nausea, vomiting, fever, and/or body aches). You may need to receive some of these drugs for some time after you receive the study drugs. Your doctor will tell you more about each of these drugs, about how they are given, and about any possible risks of receiving them.
Study Visits:
Within 3 days before each cycle, blood (about 1 tablespoon) will be drawn for routine tests.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
- Women who are able to become pregnant will have a routine urine pregnancy test done.
Each week while you are on study, blood (about 1 teaspoon) will be drawn for routine tests.
Every 6 weeks, you will have the same imaging (CT and/or MRI) scans that you had at screening to check the status of the disease. If the doctor thinks it is needed, you will have a bone scan.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit:
After you stop receiving the study drugs, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will be asked about any side effects you may have had.
- You will have the same imaging (CTand /or MRI) scans that you had at screening to check the status of the disease.
- Women who are able to become pregnant will have a routine urine pregnancy test done.
Follow-up:
Every 3 months for up to 2 years after you stop receiving the study drugs, you will be called and asked about how you are doing and about any other drugs you may be receiving. Each call will last about 3 minutes.
This is an investigational study. Carboplatin and paclitaxel are FDA approved and commercially available for the treatment of a variety of cancers including breast, lung, and ovarian cancers. Oblimersen is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genasense + Paclitaxel + Carboplatin | Experimental | Drug: Genasense, Drug: Paclitaxel, Drug: CarboplatinGenasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have a history of uveal melanoma and documented metastatic disease
- Patients must have at least one measurable lesion as per revised RECIST Criteria. A measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT slice is </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not considered measurable.
- Patients may be previously untreated or may have received prior systemic therapy but no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for metastatic disease.
- At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting GCP therapy.
- At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.
Key exclusion criteria (14 listed)
- Patients who have received prior therapy with Genasense, any taxane or any of cisplatin analogues for systemic disease.
- Patients whose site of primary melanoma is not in the choroid.
- Patients who have a current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate or cervix or other cancers treated for cure and with a disease-free survival longer than 2 years.
- Patients with brain metastasis or history of brain metastasis (es).
- Patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| GenasenseAlso: G3139, Oblimersen900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle. | Drug | Genasense + Paclitaxel + Carboplatin |
| PaclitaxelAlso: Taxol175 mg/m^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense. | Drug | Genasense + Paclitaxel + Carboplatin |
| CarboplatinAlso: ParaplatinCarboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks. The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC). | Drug | Genasense + Paclitaxel + Carboplatin |
Primary outcome
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
Time frame: Following two 3-week cycles
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Number of Participants With Response
Time frame: Following two 3-week cycles
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Sapna P. Patel, MD principal investigator
UT MD Anderson Cancer Center
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 Genasense, Paclitaxel and Carboplatin in people with Melanoma, run by M.D. Anderson Cancer 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 12 inclusion and 14 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 11 Feb 2016. 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 11 Feb 2016). 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?
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response) (time frame: Following two 3-week cycles). 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 11 Feb 2016.