Solid TumorsPhase 1NCT01336842
Study of Cisplatin and Pemetrexed in Combination With Panobinostat in Solid Tumors
A Phase 1 study testing Panobinostat, Cisplatin, Pemetrexed in people with Solid Tumors and Non-Small Cell Lung Cancer (NSCLC), run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed can be used safely without increasing side effects and that the combination will have a better effect than platinum-based doublet chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Panobinostat, Cisplatin, Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jun 2017
- 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
- Histological or cytological proven advanced solid tumors for which curative standard treatments are not available.
- Must have measurable or evaluable disease.
- Male or female patients aged ≥ 18 years old.
- Any number of prior chemotherapy regimens.
- ECOG Performance Status of ≤ 2 with a life expectancy greater than 3 months.
- Clinically euthyroid (may be on thyroid hormone replacement)
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- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of study treatment.
- Ability to provide written informed consent
- Must meet the following laboratory criteria:
- Hematology:
- Neutrophil count of ≥ 1.5 x 109/L
- Platelet count of ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Biochemistry:
- AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
- Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN and ≤ ULN
- Serum potassium ≥ LLN and ≤ ULN
- Serum sodium ≥ LLN and ≤ ULN
- Serum albumin ≥ LLN or 3g/dl
- Serum magnesium ≥ LLN and ≤ ULN
- Any elevated Alkaline Phosphatase due to bone metastasis can be enrolled
Who cannot join
- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer.
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment.
- Patients who have received chemotherapy, any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Impaired cardiac function
- Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
- Concomitant use of drugs which are generally recognized to have a risk of causing torsades de pointes where such treatment cannot be discontinued or switched to a different medication prior to starting study drug
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- Patients with unresolved diarrhea ≥ CTCAE grade 2
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat. Inability to swallow panobinostat capsules whole.
- Concomitant use of any anti-cancer therapy or radiation therapy
- Uncontrolled or symptomatic brain metastases.
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
- Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment.
- Known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Health System
Detroit, Michigan, 48202
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase I Trial of Cisplatin and Pemetrexed in Combination With Panobinostat in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer
The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed can be used safely without increasing side effects and that the combination will have a better effect than platinum-based doublet chemotherapy alone.
Read the detailed description
The purpose of this phase I study of oral panobinostat plus cisplatin and pemetrexed is to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) in patients with advanced solid tumors, with an emphasis in non-small cell lung cancer. Another purpose of this study is to find out if oral panobinostat in combination with cisplatin and pemetrexed can be administered safely without significant increase in toxicity and that the combination will increase efficacy compared to platinum-based doublet chemotherapy alone.
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Panobinostat, Cisplatin, Pemetrexed
- Keywords
- panobinostat, cisplatin, pemetrexed, dose escalation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panobinostat, Cisplatin, PemetrexedDrug
Also called LBH-589, Platinol, Almita
Drug: Panobinostat Oral (by mouth) once daily every Monday, Wednesday, and Friday for the first two weeks of each three week cycle (as per dose escalation schedule (dose levels 1 and 2: AUC 5; dose levels 3 and 4: AUC 6). Number of cycles: 6 maximum.
Drug: Cisplatin IV (in the vein) on day 1 of a 21-day cycle Number of cycles: 6 maximum. Drug: Pemetrexed IV (in the vein) on day 1 of a 21-day cycle Other: Correlative studies Biomarker Analysis: blood collected pre-study and Cycles 2-6, Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Phase I dose-escalation | Experimental | Drug: panobinostat Drug: cisplatin Drug: pemetrexed Other: Biomarker studies Receives: Drug: Panobinostat, Cisplatin, Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of oral panobinostat in combination with cisplatin and pemetrexed
Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance of physical examination. Safety and tolerability will be assessed according to the NCI CTCAE v4.
Measured: Within ±3 days of the scheduled day of assessment except for adverse events that will be evaluated continuously through the study. The expected time frame for this outcome measure is 18 weeks (or six cycles)
Secondary outcomes (4)
Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0
Determination of maximum tolerated dose (MTD) will be based on cycle 1 toxicities
Measured: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Dose-limiting toxicities and toxicity profile as assessed by NCI CTCAE, Version 4.0
Dose-limiting toxicity (DLT) will be based on cycle 1 toxicities.
Measured: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Exploratory biomarker analysis
Molecular markers predictive for response to panobinostat remain unknown. This trial offers the opportunity to retrospectively study biomarkers and their association with clinical outcomes.
Measured: Blood specimens will be collected prior to treatment, prior to Cycles 2-6. In addition, a blood specimen will be collected if the patient is removed from the study due to progression of disease. the expected time frame is 18 weeks (or 6 cycles)
Efficacy of oral panobinostat in combination with cisplatin/pemetrexed in an expanded cohort of patients with NSCLC
Response rate will be assessed by CT scan. CT scans will be performed at baseline and every two cycles. The evaluation of response will be based on standard RECIST criteria.
Measured: CT scans will be performed at baseline and every two cycles; the expected time frame is 18 weeks (or 6 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David Gandara, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336842
- Sponsor's protocol ID
- UCDCC#220
- Other IDs
- 222274, CLBH589BUS31T
- Status last verified
- Jan 2018
- First submitted
- 11 Apr 2011
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Cisplatin and Pemetrexed in Combination With Panobinostat in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01336842
- Acronym / sponsor ID
- UCDCC#220
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer (NSCLC)
- Keywords
- panobinostat, cisplatin, pemetrexed, dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Apr 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 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 purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed can be used safely without increasing side effects and that the combination will have a better effect than platinum-based doublet chemotherapy alone.
Detailed description
The purpose of this phase I study of oral panobinostat plus cisplatin and pemetrexed is to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) in patients with advanced solid tumors, with an emphasis in non-small cell lung cancer. Another purpose of this study is to find out if oral panobinostat in combination with cisplatin and pemetrexed can be administered safely without significant increase in toxicity and that the combination will increase efficacy compared to platinum-based doublet chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I dose-escalation | Experimental | Drug: Panobinostat, Cisplatin, PemetrexedDrug: panobinostat Drug: cisplatin Drug: pemetrexed Other: Biomarker studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histological or cytological proven advanced solid tumors for which curative standard treatments are not available.
- Must have measurable or evaluable disease.
- Male or female patients aged ≥ 18 years old.
- Any number of prior chemotherapy regimens.
- ECOG Performance Status of ≤ 2 with a life expectancy greater than 3 months.
Key exclusion criteria (14 listed)
- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer.
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment.
- Patients who have received chemotherapy, any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Impaired cardiac function
- Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
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 |
|---|---|---|
| Panobinostat, Cisplatin, PemetrexedAlso: LBH-589, Platinol, AlmitaDrug: Panobinostat Oral (by mouth) once daily every Monday, Wednesday, and Friday for the first two weeks of each three week cycle (as per dose escalation schedule (dose levels 1 and 2: AUC 5; dose levels 3 and 4: AUC 6). Number of cycles: 6 maximum. Drug: Cisplatin IV (in the vein) on day 1 of a 21-day cycle Number of cycles: 6 maximum. Drug: Pemetrexed IV (in the vein) on day 1 of a 21-day cycle Other: Correlative studies Biomarker Analysis: blood collected pre-study and Cycles 2-6, Day 1. | Drug | Phase I dose-escalation |
Primary outcome
Safety and feasibility of oral panobinostat in combination with cisplatin and pemetrexed
Time frame: Within ±3 days of the scheduled day of assessment except for adverse events that will be evaluated continuously through the study. The expected time frame for this outcome measure is 18 weeks (or six cycles)
Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance of physical examination. Safety and tolerability will be assessed according to the NCI CTCAE v4.
4 secondary outcomes
Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0
Time frame: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Dose-limiting toxicities and toxicity profile as assessed by NCI CTCAE, Version 4.0
Time frame: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Exploratory biomarker analysis
Time frame: Blood specimens will be collected prior to treatment, prior to Cycles 2-6. In addition, a blood specimen will be collected if the patient is removed from the study due to progression of disease. the expected time frame is 18 weeks (or 6 cycles)
Efficacy of oral panobinostat in combination with cisplatin/pemetrexed in an expanded cohort of patients with NSCLC
Time frame: CT scans will be performed at baseline and every two cycles; the expected time frame is 18 weeks (or 6 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 9 Jan 2018.
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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 Gandara, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Panobinostat, Cisplatin, Pemetrexed in people with Solid Tumors and Non-Small Cell Lung Cancer (NSCLC), run by University of California, Davis at 2 sites 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 23 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Safety and feasibility of oral panobinostat in combination with cisplatin and pemetrexed (time frame: Within ±3 days of the scheduled day of assessment except for adverse events that will be evaluated continuously through the study. The expected time frame for this outcome measure is 18 weeks (or six 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 9 Jan 2018.