MalignanciesPhase 1NCT00316511
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
A Phase 1 study testing Aroplatin in people with Malignancies and B-Cell Lymphoma, run by Agenus Inc. at 2 sites in United States.
Trial summary
This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies, B-Cell Lymphoma
- What is being tested?
- Aroplatin
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Jun 2008
- 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
- Advanced solid malignancies or B-cell lymphoma
- Less than or equal to 5 anti-cancer treatment regimens, which must be concluded at least four weeks prior to the first planned L-NDDP administration
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- New York Heart Association (NYHA) Class I or II
- Greater than or equal to 18 years of age
Show all 15Show fewer
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Platelets greater than or equal to 100 x 10^9/L
- Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
- ALT less than 3 x ULN in absence of liver metastases; less than 5 x ULN in presence of liver metastases.
- Hemoglobin greater than or equal to 10 g/dL
- Total bilirubin less than or equal to 2 x ULN
- Female of childbearing potential must have a negative serum pregnancy test
- Male or female patients of child producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for one month after the last L-NDDP dose.
- Signed written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and the rules followed at each institution.
Who cannot join
- Known active or untreated brain metastases
- Other ongoing systemic cancer therapies
- Hypersensitivity to platinum compounds
- Other active malignancies with the exception of adequately treated in-situ carcinoma of the uterine cervix, or non-melanoma skin cancer
- A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration [at least two assessments at a minimum of 48 hours apart] of a QTc interval of > 450 for males and > 470 for females) or history of additional risk factors for torsades des pointes or use of concomitant medication prolonging the QT/QTc interval
- Serious illness which, in the opinion of the Principal Investigator, would prevent study completion
- Investigational therapy currently or within four weeks prior to planned first dose of L-NDDP
- Women who are pregnant or breastfeeding will be excluded from participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Boston, Massachusetts
Study site
Houston, Texas
About this study
Official title: A Phase 1 Multi-Center, Dose Escalation and Pharmacokinetic Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be enrolled at that dose level. While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity, or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma patients will be assessed using the International Working Group recommendations.
Read the detailed description
This is a dose escalation study that utilizes a constant incremental dose increase of 50 mg/m2 per cohort. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. DLT is defined as any adverse event (AE) of severity grade 3, 4 or 5 (including serious or life-threatening) considered possibly, probably or definitely related to L-NDDP (CTCAE v3.0), which occurs during cycle 1, excluding those events that occur and are completely resolved within 4-6 hours of the first dose of L-NDDP (infusion-related reactions). This study also aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP, defined as the dose level at which no more than one out of six patients has any DLT. Once the MTD has been determined, an additional four patients will be enrolled at that dose level (for a total of 10 patients at the MTD dose level). While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration through whole blood, plasma, and urine samples drawn before, during, and after L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the RECIST criteria. Clinical activity of L-NDDP in B-Cell lymphoma patients will be assessed using the International Working Group Recommendations.
- Conditions
- Malignancies, B-Cell Lymphoma
- Being tested
- Aroplatin
- Keywords
- advanced solid malignancies, B-cell lymphoma, Aroplatin, L-NDDP, MTD, advanced solid malignancies or B-cell lymphoma
- Medical subject headings
- Neoplasms, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AroplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDP
Assess safety of L-NDDP
Determine the pharmacokinetic profile of L-NDDP
Secondary outcomes (1)
Assess clinical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- 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
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316511
- Sponsor's protocol ID
- C-726-05
- Status last verified
- Oct 2008
- First submitted
- 19 Apr 2006
- Last updated
- 27 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Center, Dose Escalation and Pharmacokinetic Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00316511
- Acronym / sponsor ID
- C-726-05
- Conditions
- Malignancies, B-Cell Lymphoma
- Keywords
- advanced solid malignancies, B-cell lymphoma, Aroplatin, L-NDDP, MTD, advanced solid malignancies or B-cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 21 Apr 2006 (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.
This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be enrolled at that dose level. While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity, or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma patients will be assessed using the International Working Group recommendations.
Detailed description
This is a dose escalation study that utilizes a constant incremental dose increase of 50 mg/m2 per cohort. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. DLT is defined as any adverse event (AE) of severity grade 3, 4 or 5 (including serious or life-threatening) considered possibly, probably or definitely related to L-NDDP (CTCAE v3.0), which occurs during cycle 1, excluding those events that occur and are completely resolved within 4-6 hours of the first dose of L-NDDP (infusion-related reactions). This study also aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP, defined as the dose level at which no more than one out of six patients has any DLT. Once the MTD has been determined, an additional four patients will be enrolled at that dose level (for a total of 10 patients at the MTD dose level). While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration through whole blood, plasma, and urine samples drawn before, during, and after L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the RECIST criteria. Clinical activity of L-NDDP in B-Cell lymphoma patients will be assessed using the International Working Group Recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Advanced solid malignancies or B-cell lymphoma
- Less than or equal to 5 anti-cancer treatment regimens, which must be concluded at least four weeks prior to the first planned L-NDDP administration
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- New York Heart Association (NYHA) Class I or II
Key exclusion criteria (8 listed)
- Known active or untreated brain metastases
- Other ongoing systemic cancer therapies
- Hypersensitivity to platinum compounds
- Other active malignancies with the exception of adequately treated in-situ carcinoma of the uterine cervix, or non-melanoma skin cancer
- A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration [at least two assessments at a minimum of 48 hours apart] of a QTc interval of > 450 for males and > 470 for females) or history of additional risk factors for torsades des pointes or use of concomitant medication prolonging the QT/QTc interval
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 |
|---|---|---|
| Aroplatin | Drug | – |
Primary outcome
Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDP
Assess safety of L-NDDP
Determine the pharmacokinetic profile of L-NDDP
1 secondary outcome
Assess clinical activity
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 27 Oct 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aroplatin in people with Malignancies and B-Cell Lymphoma, run by Agenus Inc. 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 15 inclusion and 8 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 27 Oct 2008. 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?
Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDP. The study lists 3 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 27 Oct 2008.