Lymphoid MalignanciesPhase 1NCT00508807
RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
A Phase 1 study testing RTA 402 in people with Lymphoid Malignancies and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary: To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoid Malignancies, Solid Tumors
- What is being tested?
- RTA 402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2009
- 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
- Age >/= 18 years
- Patient must have histopathological documentation of solid tumor or lymphoid malignancy. (measurable disease is not required)
- Patient must have advanced or metastatic cancer that are either refractory or has relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. (there is no limit on the number of prior lines of therapy)
- Patient must be ECOG performance status of less than or equal to 2.
- Patient must have adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy:
- total bilirubin </= 1.5 mg/dL
Show all 18Show fewer
- AST (SGOT) and ALT(SGPT) </= 2.5 ULN or
- </= 5 ULN if liver is involved by tumor
- creatinine </= 2.0 mg/dL OR creatinine clearance > 60 mL/min
- Patient must have adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy:
- platelets greater than 100,000/mm^3,
- absolute granulocyte count greater than 1,500/mm^3,
- hemoglobin greater than or equal to 8.0 g/dl.
- Patient must have completed prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy at least 4 weeks prior to starting RTA 402, and must have recovered from all acute side effects (to CTC grade 1 or less) prior to initiation of RTA 402. Patients who were receiving mitomycin C or nitrosoureas must be 6 weeks from the last administration of chemotherapy.
- Patient (man or woman) must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
- Patient must have a life expectancy of more than 3 months.
- Patient must be able and willing to sign the informed consent form.
- Patient must be willing and able to self-administer orally and document all doses of RTA 402 ingested.
Who cannot join
- Patients with active brain metastases or primary CNS malignancies. (patients with a previously treated brain metastasis may be included)
- Patients who are pregnant or breast feeding
- Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to:
- uncontrolled diabetes
- active or uncontrolled infection
- acute or chronic liver disease (i.e., hepatitis, cirrhosis)
Show all 12Show fewer
- confirmed diagnosis of HIV infection
- uncontrolled hypertension, symptomatic congestive heart failure,
- unstable angina pectoris,
- myocardial infarction within the past 6 months, or
- uncontrolled cardiac arrhythmia.
- Patients with psychiatric illness that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies
Primary:
- To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.
- To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days in this patient population.
Read more
Secondary:
- To document any preliminary antitumor activity of RTA 402 in this patient population.
- To determine the in vivo molecular and biological effects of RTA 402 by measuring changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs, blood plasma, and, in consenting patients, tumor biopsies.
- To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements
- To evaluate the series of inflammation related symptoms over the course of the study, and to determine the correlation of symptom intensity with plasma cytokines.
Read the detailed description
RTA 402 is a new man-made drug that is designed to inhibit (turn off) genes that may activate your cancer cells and cause them to grow. This drug has not been tested in humans.
If you are found to be eligible to take part in this study, you will take RTA 402 by mouth (several capsules a day) in the morning with a glass of water (before eating) on the dose level that will be assigned to you. The dose level you receive will depend on when you begin on this study. You will receive the study drug for 21 days in a row. You will not take the study drug for the next 7 days. This is considered a rest period. These 28 days equal 1 cycle. You should take your study drug as instructed. If a dose is missed or vomited, it will not be replaced either on that day or at the end of the 21-day treatment period.
At the beginning of the study, one to three patients may be enrolled at each dose level, and dose will be doubled between groups until the first occurrence of intolerable side effects during Cycle 1. At the first occurrence of less severe side effects, groups will be expanded to 3-4 patients. Dose escalation (increasing) will continue in this way until researchers learn the highest dose that is best tolerated. You will remain at the same dose level that you started on for at least 2 cycles. After at least 2 cycles, your dose may be increased to another dose that has been determined to be safe. If your disease gets worse or you experience any intolerable side effects, you will be taken off this study.
On Cycle 1 on Days 1 and 21, you will be asked to go to the Clinical and Translational Research Center for your dose of the study drug. You will be asked about how you are feeling, and about any medications you may be taking including any over the counter medication, herbs, and alcohol. You will be asked to report any bad side effects you may experience from the study drug. You will have blood draws (about 1 1/2 teaspoons each time) for PK studies. You will have these PK blood draws before you take RTA 402 at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, and 24 hours after you take the study drug. You will have your vital signs measured at 2, 4, and 8 hours after taking RTA 402. You will have your urine collected over a 24-hour period. The study staff will provide the urine sample container and explain how to collect your urine.
During Cycle 1, you will return to the clinic every week to have routine blood drawn (about 2 teaspoons) to check the status of your disease. You will be asked how you are feeling and about any medications you may be taking including any over the counter medication, herbs, and alcohol.
Each week during Cycle 1 and on Day 28 of each additional cycle, you will complete 2 questionnaires that will take about 15 minutes to complete. You will also have your body weight measured and be asked about your normal food intake. Your body composition will be measured using measurements that include body weight and height, skin fold thickness, and bioelectrical impedance using the Tanita body composition monitoring scale. This is a non-invasive method to measure total body water, total body fat, and total body lean mass. Researchers will measure how much energy your body uses while at rest. You will also have timed test that will involve your participation where at your fastest speed you will be asked to walk 25 feet and walk back.
After Cycle 1, you will return to the clinic every other week for up to 18 cycles (about 18 months) as long as your health does not get worse and you do not experience any intolerable side effects.
During every other cycle starting with Cycle 2, you will be evaluated to check the status of your cancer. You will have routine imaging studies, such as x-rays, CT scans, or MRIs to measure your tumor. You will have a bone marrow biopsy (if you have lymphoid disease) to measure your disease. On Day 1 of the next cycle, you will return to your doctor's office for your next physical exam and to begin the next cycle of the study drug.
While on this study, you will not be allowed to take any other investigational agent, chemotherapy, biologic therapy, immunotherapy, or anti-cancer treatments. You will not be allowed to take medicine that can help increase your white blood cell count.
Once you have completed all cycles of the study drug, you will have an end-of-study visit. During this visit, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 1/2 teaspoons) for routine tests, and a urine sample will be collected. You will have a bone marrow biopsy (if you have lymphoid disease) to measure your disease. You will have imaging studies, such as x-rays, CT scans, or MRIs to measure your tumor. You will be asked to report any side effects or new medications that you may be taking including any over the counter medication, herbs, and alcohol.
You will be followed (30 days after you are off study) and asked to report any side effects you may be experiencing, or new medications that you may be taking. You will also have a physical exam, including measurement of your vital signs. If your doctor thinks that you should continue taking RTA 402 (after 18 cycles or 18 months), you will be asked to participate in an extended study.
This is an investigational study. RTA 402 has been authorized by the FDA for use in research only. Up to 45 patients will take part in this multicenter study. Up to 42 will be enrolled at M. D. Anderson.
- Conditions
- Lymphoid Malignancies, Solid Tumors
- Being tested
- RTA 402
- Keywords
- Lymphoid Malignancies, Solid Tumors, RTA 402
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTA 402Drug
5 mg by mouth (PO) daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| RTA 402 | Experimental | 5 mg PO daily x 21 days Receives: Drug: RTA 402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of RTA 402
Measured: 28 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid MalignanciesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Reata Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- David S. Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508807
- Sponsor's protocol ID
- 2005-0984
- Status last verified
- Jul 2012
- First submitted
- 26 Jul 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00508807
- Acronym / sponsor ID
- 2005-0984
- Conditions
- Lymphoid Malignancies, Solid Tumors
- Keywords
- Lymphoid Malignancies, Solid Tumors, RTA 402
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Reata Pharmaceuticals, Inc.
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Jul 2007 (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.
Primary:
- To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.
- To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days in this patient population.
Secondary:
- To document any preliminary antitumor activity of RTA 402 in this patient population.
- To determine the in vivo molecular and biological effects of RTA 402 by measuring changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs, blood plasma, and, in consenting patients, tumor biopsies.
- To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements
- To evaluate the series of inflammation related symptoms over the course of the study, and to determine the correlation of symptom intensity with plasma cytokines.
Detailed description
RTA 402 is a new man-made drug that is designed to inhibit (turn off) genes that may activate your cancer cells and cause them to grow. This drug has not been tested in humans.
If you are found to be eligible to take part in this study, you will take RTA 402 by mouth (several capsules a day) in the morning with a glass of water (before eating) on the dose level that will be assigned to you. The dose level you receive will depend on when you begin on this study. You will receive the study drug for 21 days in a row. You will not take the study drug for the next 7 days. This is considered a rest period. These 28 days equal 1 cycle. You should take your study drug as instructed. If a dose is missed or vomited, it will not be replaced either on that day or at the end of the 21-day treatment period.
At the beginning of the study, one to three patients may be enrolled at each dose level, and dose will be doubled between groups until the first occurrence of intolerable side effects during Cycle 1. At the first occurrence of less severe side effects, groups will be expanded to 3-4 patients. Dose escalation (increasing) will continue in this way until researchers learn the highest dose that is best tolerated. You will remain at the same dose level that you started on for at least 2 cycles. After at least 2 cycles, your dose may be increased to another dose that has been determined to be safe. If your disease gets worse or you experience any intolerable side effects, you will be taken off this study.
On Cycle 1 on Days 1 and 21, you will be asked to go to the Clinical and Translational Research Center for your dose of the study drug. You will be asked about how you are feeling, and about any medications you may be taking including any over the counter medication, herbs, and alcohol. You will be asked to report any bad side effects you may experience from the study drug. You will have blood draws (about 1 1/2 teaspoons each time) for PK studies. You will have these PK blood draws before you take RTA 402 at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, and 24 hours after you take the study drug. You will have your vital signs measured at 2, 4, and 8 hours after taking RTA 402. You will have your urine collected over a 24-hour period. The study staff will provide the urine sample container and explain how to collect your urine.
During Cycle 1, you will return to the clinic every week to have routine blood drawn (about 2 teaspoons) to check the status of your disease. You will be asked how you are feeling and about any medications you may be taking including any over the counter medication, herbs, and alcohol.
Each week during Cycle 1 and on Day 28 of each additional cycle, you will complete 2 questionnaires that will take about 15 minutes to complete. You will also have your body weight measured and be asked about your normal food intake. Your body composition will be measured using measurements that include body weight and height, skin fold thickness, and bioelectrical impedance using the Tanita body composition monitoring scale. This is a non-invasive method to measure total body water, total body fat, and total body lean mass. Researchers will measure how much energy your body uses while at rest. You will also have timed test that will involve your participation where at your fastest speed you will be asked to walk 25 feet and walk back.
After Cycle 1, you will return to the clinic every other week for up to 18 cycles (about 18 months) as long as your health does not get worse and you do not experience any intolerable side effects.
During every other cycle starting with Cycle 2, you will be evaluated to check the status of your cancer. You will have routine imaging studies, such as x-rays, CT scans, or MRIs to measure your tumor. You will have a bone marrow biopsy (if you have lymphoid disease) to measure your disease. On Day 1 of the next cycle, you will return to your doctor's office for your next physical exam and to begin the next cycle of the study drug.
While on this study, you will not be allowed to take any other investigational agent, chemotherapy, biologic therapy, immunotherapy, or anti-cancer treatments. You will not be allowed to take medicine that can help increase your white blood cell count.
Once you have completed all cycles of the study drug, you will have an end-of-study visit. During this visit, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 1/2 teaspoons) for routine tests, and a urine sample will be collected. You will have a bone marrow biopsy (if you have lymphoid disease) to measure your disease. You will have imaging studies, such as x-rays, CT scans, or MRIs to measure your tumor. You will be asked to report any side effects or new medications that you may be taking including any over the counter medication, herbs, and alcohol.
You will be followed (30 days after you are off study) and asked to report any side effects you may be experiencing, or new medications that you may be taking. You will also have a physical exam, including measurement of your vital signs. If your doctor thinks that you should continue taking RTA 402 (after 18 cycles or 18 months), you will be asked to participate in an extended study.
This is an investigational study. RTA 402 has been authorized by the FDA for use in research only. Up to 45 patients will take part in this multicenter study. Up to 42 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTA 402 | Experimental | Drug: RTA 4025 mg PO daily x 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age >/= 18 years
- Patient must have histopathological documentation of solid tumor or lymphoid malignancy. (measurable disease is not required)
- Patient must have advanced or metastatic cancer that are either refractory or has relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. (there is no limit on the number of prior lines of therapy)
- Patient must be ECOG performance status of less than or equal to 2.
- Patient must have adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy:
Key exclusion criteria (12 listed)
- Patients with active brain metastases or primary CNS malignancies. (patients with a previously treated brain metastasis may be included)
- Patients who are pregnant or breast feeding
- Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to:
- Patients with psychiatric illness that would limit compliance with study requirements
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 |
|---|---|---|
| RTA 4025 mg by mouth (PO) daily for 21 days | Drug | RTA 402 |
Primary outcome
Maximum Tolerated Dose of RTA 402
Time frame: 28 day cycles
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 30 Jul 2012.
- 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.
David S. Hong, MD principal investigator
M.D. 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 1 study testing RTA 402 in people with Lymphoid Malignancies and Solid Tumors, 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 18 inclusion and 12 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 30 Jul 2012. 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?
Maximum Tolerated Dose of RTA 402 (time frame: 28 day cycles). 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 30 Jul 2012.