Non-Hodgkin's LymphomaPhase 1/2NCT00499239
A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
A Phase 1/2 study testing GS-9219 in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 20 sites in 3 countries.
Trial summary
Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma
- What is being tested?
- GS-9219
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Jul 2007to Oct 2010
- Phase
- Phase 1/2
- 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
- Relapsed or refractory CLL, NHL or MM
- ECOG Performance Status of 0, 1, or 2
- Adequate organ function (protocol defined)
- ECG without evidence of clinically significant ventricular arrhythmias
Who cannot join
- AIDS-related lymphoma
- Subjects with NHL who present exclusively with non-measurable lesions
- Subjects with MM who have non-secretory and/or non-measurable disease
- Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
- Evidence of pulmonary fibrosis
- Other concurrent malignancy
Show all 9Show fewer
- Uncontrolled concurrent illness
- Receiving chronic, systemically administered steroids
- Known hypersensitivity to nucleoside analogues
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Russia10 sites
State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences
Kaluga Region, 249036
State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia
Moscow, 105229
State Institution Hematological Research Center under the Russian Academy of Medical Sciences
Moscow, 125167
Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin
Moscow, 125284
Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"
Moscow, 129128
State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care
Saint Petersburg, 191024
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Institute of Hematology and Transplantology n.a. R.M. Gorbacheva
Saint Petersburg, 197022
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
Saint Petersburg, 197022
Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care
Saint Petersburg, 197758
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
MD Anderson Cancer Center
Houston, Texas, 77303
Nevada Cancer Institute
Las Vegas, Nevada, 89135
UCSF
San Francisco, California, 94143
Czechia5 sites
Fakultni nemocnice Brno - Bohunice
Brno, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500
Fakultni nemocnice Olomouc
Olomouc, 775 20
Fakultni nemocnice Kralovske Vinohrady
Prague, 10 100 34
Vseobecna fakultni nemocnice
Prague, 2 128 08
About this study
Official title: Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma
Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.
Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.
Read the detailed description
The primary objective of this study is as follows:
To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).
The secondary objectives of this study are as follows:
To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient population.
To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response. Progression-free Survival and Overall Survival will be assessed if applicable.
- Being tested
- GS-9219
- Keywords
- Hematologic Malignancies, CLL, NHL, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, CLL and NHL, Multiple Myeloma, MM
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9219Drug
GS-9219 Injection is a clear, and colorless to slightly yellow aqueous solution containing 4 mg/mL of GS 9219.
GS 9219 will be administered via IV infusion over 30 minutes in 100 mL of normal saline solution, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| GS-9219 | Experimental | Escalating doses of GS-9219 (5, 8, 11.5, 16, 22.5, 31.5, 44, and 61.5 mg/m^2) until determination of the maximum tolerated dose (MTD) Receives: Drug: GS-9219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTD
Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experience a dose-limiting toxicity (DLT).
Measured: All visits
Secondary outcomes (3)
Pharmacokinetics of GS-9219 and its metabolites
Pharmacokinetics (Cmax, Tmax, Clast, Tlast, λz, t1/2, AUClast, AUCinf, and %AUCexp) measured by blood sampling
Measured: AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Response rate
Response rate measured by:
- CLL: National Cancer Institute Working Group (NCIWG) criteria
- NHL - National Cancer Institute (NCI) criteria; Response Evaluation in
- MM - International Myeloma Working Group (IMWG) criteria.
Measured: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Duration of response
Duration of response measured by:
- CLL: National Cancer Institute Working Group (NCIWG) criteria
- NHL - National Cancer Institute (NCI) criteria; Response Evaluation in
- MM - International Myeloma Working Group (IMWG) criteria.
Measured: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2010
- Study completionOct 2010
Why it stopped: Unacceptable safety profile
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hawkins, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499239
- Sponsor's protocol ID
- GS-US-193-0101
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2007
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00499239
- Acronym / sponsor ID
- GS-US-193-0101
- Keywords
- Hematologic Malignancies, CLL, NHL, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, CLL and NHL, Multiple Myeloma, MM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unacceptable safety profile
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 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.
Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.
Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.
Detailed description
The primary objective of this study is as follows:
To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).
The secondary objectives of this study are as follows:
To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient population.
To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response. Progression-free Survival and Overall Survival will be assessed if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GS-9219 | Experimental | Drug: GS-9219Escalating doses of GS-9219 (5, 8, 11.5, 16, 22.5, 31.5, 44, and 61.5 mg/m^2) until determination of the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed or refractory CLL, NHL or MM
- ECOG Performance Status of 0, 1, or 2
- Adequate organ function (protocol defined)
- ECG without evidence of clinically significant ventricular arrhythmias
Key exclusion criteria (9 listed)
- AIDS-related lymphoma
- Subjects with NHL who present exclusively with non-measurable lesions
- Subjects with MM who have non-secretory and/or non-measurable disease
- Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
- Evidence of pulmonary fibrosis
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 |
|---|---|---|
| GS-9219GS-9219 Injection is a clear, and colorless to slightly yellow aqueous solution containing 4 mg/mL of GS 9219. GS 9219 will be administered via IV infusion over 30 minutes in 100 mL of normal saline solution, every 21 days. | Drug | GS-9219 |
Primary outcome
Determination of MTD
Time frame: All visits
Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). The MTD will be the highest dose level immediately below the dose level where two or more of three to six patients experience a dose-limiting toxicity (DLT).
3 secondary outcomes
Pharmacokinetics of GS-9219 and its metabolites
Time frame: AAA) CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Response rate
Time frame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Duration of response
Time frame: CLL/NHL: at Cycles 1, 3, and 6: MM: Cycles 1, 2, 3, 4, 5, and 6
Results and safety
The study was stopped early (reason given: Unacceptable safety profile). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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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.
Michael Hawkins, MD study director
Gilead Sciences
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GS-9219 in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 20 sites in 3 countries.
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 4 inclusion and 9 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 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia, United States, Czechia. 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 combined 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.
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?
The study was stopped early (reason given: Unacceptable safety profile). Results are not available in the source record.
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?
Determination of MTD (time frame: All visits). 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 4 Feb 2014.