Breast CancerPhase 1NCT01333423
Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 1 study testing Liposomal Doxorubicin and Seliciclib in people with Breast Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Liposomal Doxorubicin and Seliciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2015
- 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
- Both male and female patients with invasive cancer that is confirmed ER/PR/HER2 negative carcinoma of the breast with locally advanced or stage IV disease that is not amenable to curative therapy. For purposes of this study, triple negative disease will be tumors that have ER/PR <10% and HER2 </=1+ by IHC or HER2 FISH non-amplified (ratio <2.0).
- Patients must have an ECOG performance status of 0, 1 or 2
- Age >/= 18 years
- Women must not be pregnant or lactating because of the teratogenic potential of these drugs. All females of childbearing potential (i.e. A female not free from menses > 1 year or not surgically sterilized) must have a blood test or urine study within 2 weeks prior to start of therapy to rule out pregnancy.
- Women of childbearing potential (i.e. A female not free from menses > 1 year or not surgically sterilized) and are strongly advised to use an accepted and effective non-hormonal method of contraception.
- Must have at least one site of objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of start of therapy.
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- Patients must be disease free of prior malignancy for >/= 5 years with the exception of curatively treated squamous cell carcinomas of the skin or carcinoma in situ of the cervix or breast.
- Patients must have no serious medical illness, other that treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consent.
- Patients must not have peripheral neuropathy > grade 2.
- Required Cardiac Parameters: Patients must not have had a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or CVA within 6 months of protocol registration. LVEF > 50% by MUGA or ECHO.
- Patients must not have history of PR prolongation or AV block
- Required laboratory parameters: Patients must have serum creatinine < 1.5 mg/dl.
- Patients must have adequate hematologic functions: granulocytes > 1500/mm^3 and platelets > 100,000/mm^3
- Patients must have adequate hepatocellular function: SGOT (AST) and SGPT (ALT) < 1.5 x upper limit of normal (unless liver is involved by tumor, in which case SGOT (AST) and SGPT (ALT) can be < 2.0 x upper limit of normal)
- Patients must have no history of prior therapy with seliciclib.
- Patients must not have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2. Patients who have received >240 mg/m^2 of doxorubicin or >400 mg/m^2 of epirubicin should be advised to undergo evaluation of left ventricular ejection fraction (LVEF) with echocardiogram (ECHO) or gated heart scan (MUGA) prior to initiating therapy.
- Concurrent use of hormonal therapy is not permitted. Concurrent radiation therapy is not permitted.
- Patients must not have had prior organ allograft or require immunosuppressive therapy.
- Patients must have completed and recovered from the effects of prior chemotherapy (</= grade 2 toxicity).
- Patients must have received at least one prior chemotherapy regimen for metastatic disease. Progression within 6 months of adjuvant chemotherapy will be considered equivalent to one prior chemotherapy for metastatic disease.
Who cannot join
- 1) None.
About this study
Official title: A Phase I With Dose Expansion to Determine the Maximum Tolerated Dose of Liposomal Doxorubicin in Combination With Seliciclib for the Treatment of Patients With Metastatic Triple Negative Breast Cancer
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
Read the detailed description
The Study Drugs:
Seliciclib is designed to stop cancer cells from dividing, which may cause them to die.
Doxorubicin is a chemotherapy drug that is designed to stop the growth of cancer cells, which may cause the cells to die. Liposomal doxorubicin is a redesigned version of doxorubicin. The drug, doxorubicin, is enclosed in a fat bubble called a liposome. This is designed to allow the drug to get into the tumor tissue better and to stay in the body for a longer time.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of seliciclib based on when you joined this study. Up to 6 dose levels of seliciclib will be tested. At least 2 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of seliciclib is found.
All participants will receive the same dose level of liposomal doxorubicin.
Drug Administration:
You will take seliciclib by mouth with a cup (8 ounces) of water twice a day on Days 1-3 of each 28-day study cycle. The 2 doses should be taken 12 hours apart. Seliciclib should be taken 1 hour before or 2 hours after a meal. If you miss a dose, it can be taken up to 2 hours after the scheduled time. If it has been more than 2 hours, the missed dose should not be taken. You should resume taking the study drug at the next normally scheduled time.
You will receive liposomal doxorubicin by vein over 2-3 hours on Day 4 of each cycle.
On Days 5-28 you will not receive any study drugs.
Study Visits:
At all study visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
During Week 2 of Cycle 1:
-Blood (about 1-2 teaspoons) will be drawn for routine tests.
You will have an ECHO or MUGA scan at least every 4 cycles to check your heart function.
After every even-numbered cycles (Cycles 2, 4, 6 and so on), you will have either a CT or MRI scan to check the status of the disease.
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 drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 4-6 weeks after you have stopped receiving the study drugs, you will have an end-of-study visit. 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 1-2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any symptoms you may be having and drugs you may be taking.
This is an investigational study. Seliciclib is not FDA-approved or commercially available. It is currently being used for research purposes only.
Liposomal doxorubicin is FDA-approved and commercially available for metastatic breast cancer. The use of these drugs together is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Liposomal Doxorubicin, Seliciclib
- Keywords
- Breast Cancer, Metastatic Triple Negative, ER/PR/HER2 negative, Locally advanced, Stage IV, Metastatic, Seliciclib, Liposomal Doxorubicin, Doxil, Doxorubicin Hydrochloride (Liposomal)
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal DoxorubicinDrug
Also called Doxil, Doxorubicin Hydrochloride (Liposomal)
40 mg by vein administered over 2 -3 hours on Day 4 of a 28 day cycle.
SeliciclibDrug
Starting dose 200 mg by mouth twice daily on Days 1 - 3 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Doxil + Seliciclib | Experimental | Doxil (Liposomal doxorubicin) 40 mg/m2 intravenous (IV) over 2 -3 hours on Day 4 and Seliciclib starting dose 200 mg orally twice a day on Days 1 - 3 of 28 day cycle Receives: Drug: Liposomal Doxorubicin; Drug: Seliciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Dose Limiting Toxicity(DLT)
Dose-limiting toxicity (DLT) defined as NCI Common Toxicity Criteria (version 4.0): Grade 3 or 4 thrombocytopenia lasting > 2 weeks; Grade 3 or 4 neutropenia lasting >2 weeks; Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity that lasts > 72 hours despite appropriate medical management (excluding grade 3 fatigue); or Delay in administration of cycle 2 of therapy for >2 weeks due to myelosuppression. DLT must be considered treatment related and occur during cycle 1 of therapy.
Measured: Cycle 1 of therapy (28 days)
Secondary outcomes (1)
Number of Participants with Clinical Response
Disease response assessed using standard imaging techniques every two cycles. Response measured and defined using modified RECIST criterias of CR, PR or SD at 6 months where Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference smallest sum of longest diameter since treatment started.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stacy Moulder, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333423
- Sponsor's protocol ID
- 2011-0013
- Other IDs
- 1R01CA152228-01A1
- Status last verified
- Jun 2012
- First submitted
- 8 Apr 2011
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I With Dose Expansion to Determine the Maximum Tolerated Dose of Liposomal Doxorubicin in Combination With Seliciclib for the Treatment of Patients With Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01333423
- Acronym / sponsor ID
- 2011-0013
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Metastatic Triple Negative, ER/PR/HER2 negative, Locally advanced, Stage IV, Metastatic, Seliciclib, Liposomal Doxorubicin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- First posted
- 12 Apr 2011 (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.
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
Detailed description
The Study Drugs:
Seliciclib is designed to stop cancer cells from dividing, which may cause them to die.
Doxorubicin is a chemotherapy drug that is designed to stop the growth of cancer cells, which may cause the cells to die. Liposomal doxorubicin is a redesigned version of doxorubicin. The drug, doxorubicin, is enclosed in a fat bubble called a liposome. This is designed to allow the drug to get into the tumor tissue better and to stay in the body for a longer time.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of seliciclib based on when you joined this study. Up to 6 dose levels of seliciclib will be tested. At least 2 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of seliciclib is found.
All participants will receive the same dose level of liposomal doxorubicin.
Drug Administration:
You will take seliciclib by mouth with a cup (8 ounces) of water twice a day on Days 1-3 of each 28-day study cycle. The 2 doses should be taken 12 hours apart. Seliciclib should be taken 1 hour before or 2 hours after a meal. If you miss a dose, it can be taken up to 2 hours after the scheduled time. If it has been more than 2 hours, the missed dose should not be taken. You should resume taking the study drug at the next normally scheduled time.
You will receive liposomal doxorubicin by vein over 2-3 hours on Day 4 of each cycle.
On Days 5-28 you will not receive any study drugs.
Study Visits:
At all study visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
During Week 2 of Cycle 1:
-Blood (about 1-2 teaspoons) will be drawn for routine tests.
You will have an ECHO or MUGA scan at least every 4 cycles to check your heart function.
After every even-numbered cycles (Cycles 2, 4, 6 and so on), you will have either a CT or MRI scan to check the status of the disease.
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 drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 4-6 weeks after you have stopped receiving the study drugs, you will have an end-of-study visit. 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 1-2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any symptoms you may be having and drugs you may be taking.
This is an investigational study. Seliciclib is not FDA-approved or commercially available. It is currently being used for research purposes only.
Liposomal doxorubicin is FDA-approved and commercially available for metastatic breast cancer. The use of these drugs together is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxil + Seliciclib | Experimental | Drug: Liposomal Doxorubicin, Drug: SeliciclibDoxil (Liposomal doxorubicin) 40 mg/m2 intravenous (IV) over 2 -3 hours on Day 4 and Seliciclib starting dose 200 mg orally twice a day on Days 1 - 3 of 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Both male and female patients with invasive cancer that is confirmed ER/PR/HER2 negative carcinoma of the breast with locally advanced or stage IV disease that is not amenable to curative therapy. For purposes of this study, triple negative disease will be tumors that have ER/PR <10% and HER2 </=1+ by IHC or HER2 FISH non-amplified (ratio <2.0).
- Patients must have an ECOG performance status of 0, 1 or 2
- Age >/= 18 years
- Women must not be pregnant or lactating because of the teratogenic potential of these drugs. All females of childbearing potential (i.e. A female not free from menses > 1 year or not surgically sterilized) must have a blood test or urine study within 2 weeks prior to start of therapy to rule out pregnancy.
- Women of childbearing potential (i.e. A female not free from menses > 1 year or not surgically sterilized) and are strongly advised to use an accepted and effective non-hormonal method of contraception.
Key exclusion criteria (1 listed)
- 1) None.
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 |
|---|---|---|
| Liposomal DoxorubicinAlso: Doxil, Doxorubicin Hydrochloride (Liposomal)40 mg by vein administered over 2 -3 hours on Day 4 of a 28 day cycle. | Drug | Doxil + Seliciclib |
| SeliciclibStarting dose 200 mg by mouth twice daily on Days 1 - 3 of a 28 day cycle. | Drug | Doxil + Seliciclib |
Primary outcome
Number of Participants with a Dose Limiting Toxicity(DLT)
Time frame: Cycle 1 of therapy (28 days)
Dose-limiting toxicity (DLT) defined as NCI Common Toxicity Criteria (version 4.0): Grade 3 or 4 thrombocytopenia lasting > 2 weeks; Grade 3 or 4 neutropenia lasting >2 weeks; Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity that lasts > 72 hours despite appropriate medical management (excluding grade 3 fatigue); or Delay in administration of cycle 2 of therapy for >2 weeks due to myelosuppression. DLT must be considered treatment related and occur during cycle 1 of therapy.
1 secondary outcome
Number of Participants with Clinical Response
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- UT MD Anderson 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.
Stacy Moulder, MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Doxorubicin and Seliciclib in people with Breast Cancer, run by M.D. Anderson Cancer Center.
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 20 inclusion and 1 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: withdrawn, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with a Dose Limiting Toxicity(DLT) (time frame: Cycle 1 of therapy (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.