Colorectal CancerPhase 1/2NCT00478946
A Study of Picoplatin in Colorectal Cancer
A Phase 1/2 study testing (FOLPI) Picoplatin with 5-FU and Leucovorin, FOLPI and FOLFOX in people with Colorectal Cancer, run by Poniard Pharmaceuticals at 16 sites in Russia.
Trial summary
Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the rectum (end of the colon). Several drugs are often given in combination to treat colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- (FOLPI) Picoplatin with 5-FU and Leucovorin, FOLPI and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 16 sitesRussia
- Study dates
- Apr 2006to Jun 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
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Metastatic disease consistent with colorectal adenocarcinoma. Stage M1, and not amenable to curative surgery. Subjects with only locally persistent or only locally recurrent disease are not eligible.
- No prior systemic therapy for metastatic cancer. Prior adjuvant chemotherapy with a 5-FU-based treatment regimen not containing oxaliplatin or irinotecan is acceptable after a treatment-free interval of at least 6 months.
- ECOG performance score (PS) of 0 or 1.
- Life expectancy more than 3 months.
- Subject must have measurable disease, defined by the RECIST criteria.
Show all 17Show fewer
- At least 28 days must have elapsed since prior surgery except venous access device placement.
- At least 28 days must have elapsed since prior radiotherapy.
- At least 28 days must have elapsed since a prior investigational agent.
- Absolute neutrophil count (ANC) equal to or greater than 1.5 x 10^9/L.
- Platelet count equal to or greater than 100 x 10^9/L.
- Hemoglobin equal or greater than 10g/dL (must be obtained at least 3 days after any transfusion).
- Serum AST and ALT levels less than or equal to 2.5 times upper limit of normal (ULN) or less than 5 times ULN if liver involvement is present.
- Serum bilirubin of less than or equal to 1.5 ULN.
- Serum creatinine of less than or equal to ULN.
- Women of childbearing potential must have a negative pregnancy test (serum or urine beta HCG).
- All subjects must agree to use appropriate birth control methods while on study and for 1 month after completion of study chemotherapy.
Who cannot join
- Concurrent use of EGFR inhibitors or anti-VEGF agents.
- No clinically significant obstructive symptoms or intestinal bleeding.
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g. Crohn's disease, ulcerative colitis, malabsorption syndrome, Grade 2+ diarrhea of any etiology at baseline).
- History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
- Clinical evidence of brain metastases or central nervous system disease.
- Symptomatic peripheral neuropathy (equivalent to Grade 2 or higher CTCAE toxicity criteria).
Show all 10Show fewer
- Uncontrolled intercurrent illness (e.g. active infection).
- Pregnant or nursing.
- Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol.
- Malignancy other than colorectal carcinoma within the past 5 years, except, curatively treated, superficial skin cancer or carcinoma in situ of the cervix or breast.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Russia16 sites
Regional Oncology Center - Phase 2
Astrakhan, 414041
Chelyabinsk Regional Oncology Center - Phase 1
Chelyabinsk, 454087
Regional Oncology Center, Chemotherapy Department - Phase 2
Engel's, 413115
Kazan Oncology Center
Kazan', 420111
Leningrad Regional Oncology Center, Chemotherapy Department - Phase 2
Kuzmolovsky Village, Vsevolozhsk, 188663
Blokhin Russian Oncology Research Center - Phase 1
Moscow, 115478
Semashko Central Clinical Hospital #2 - Phase 1
Moscow, 129128
Medical Radiology Research Center of Russian Academy of Medical Sciences- Phase 1
Obninsk, 249036
Republic Oncology Center of the Ministry of Healthcare of Karelia Republic - Phase 2
Petrozavodsk, 185007
Rostov Research Institute of Oncology- Phase 2
Rostov-na-Dony, 350086
St. Petersburg Academy of Postgraduate Education - Phase 2
Saint Petersburg, 194291
St. Petersburg Mechnikov State Medical Academy - Phase 2
Saint Petersburg, 195067
St. Petersburg City Oncology Center - Phase 1
Saint Petersburg, 198255
Regional Clinical Oncology Center - Phase 2
Ulyanovsk, 432063
Voronezh Regional Clinical Oncology Center - Phase 2
Voronezh, 394000
Yaroslavl Regional Oncology Center - Phase 1
Yaroslavl, 150054
About this study
Official title: A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer
Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the rectum (end of the colon). Several drugs are often given in combination to treat colorectal cancer. One of the most active treatment combinations is known as FOLFOX, which is a combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of platinum drug and was approved by the FDA in 2004. While generally well-tolerated, oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity.
Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No significant nerve toxicity has been seen in previous studies of picoplatin.
This study will review the safety and effectiveness of FOLPI, which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer.
Read the detailed description
Subjects will be randomized centrally to treatment with picoplatin administered either every two or every four weeks and will be assigned a dose of picoplatin dependent on the study results to date. Each patient will also receive therapy every two weeks with 5-FU and leucovorin. In each schedule, the cohort size will be 3 subjects, to be expanded to 6 subjects if a dose-limiting toxicity is observed. If not dose-limiting toxicity observed among the 3 subjects within a cohort, picoplatin dose escalation may proceed, until the maximum tolerated dose is established.
- Conditions
- Colorectal Cancer
- Being tested
- (FOLPI) Picoplatin with 5-FU and Leucovorin, FOLPI, FOLFOX
- Keywords
- colorectal cancer, picoplatin, FOLFOX, FOLPI, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(FOLPI) Picoplatin with 5-FU and LeucovorinDrug
Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
FOLPIDrug
Picoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
FOLFOXDrug
Oxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion. Receives: Drug: (FOLPI) Picoplatin with 5-FU and Leucovorin; Drug: FOLPI |
| 2 | Active comparator | FOLFOX Oxaliplatin 85 mg/m2, as a 2-hour infusion Leucovorin (400 mg/m2 in D5W) and Oxaliplatin. Leucovorin + oxaliplatin will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion. Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicity
Measured: within the first four weeks of treatment
maximum tolerated dose
Measured: within the first two cycles of treatment
Secondary outcomes (1)
safety and efficacy
Measured: duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poniard Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Earhart, MD, PhD, Study director, Poniard Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478946
- Sponsor's protocol ID
- 0501
- Status last verified
- Jan 2009
- First submitted
- 23 May 2007
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
PubMed 12645909Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
PubMed 12671715Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74.
PubMed 9815598Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
PubMed 9474239Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
PubMed 9472630Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
PubMed 12142057Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
PubMed 12441268Plasencia C, Abad A, Martinez-Balibrea E, Taron M. Antiproliferative effects of ZD0473 (AMD473) in combination with 5-fluorouracil or SN38 in human colorectal cancer cell lines. Invest New Drugs. 2004 Nov;22(4):399-409. doi: 10.1023/B:DRUG.0000036682.99818.71.
PubMed 15292710Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0.
PubMed 12645906
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00478946
- Acronym / sponsor ID
- 0501
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, picoplatin, FOLFOX, FOLPI, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Poniard PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 25 May 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.
Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the rectum (end of the colon). Several drugs are often given in combination to treat colorectal cancer. One of the most active treatment combinations is known as FOLFOX, which is a combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of platinum drug and was approved by the FDA in 2004. While generally well-tolerated, oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity.
Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No significant nerve toxicity has been seen in previous studies of picoplatin.
This study will review the safety and effectiveness of FOLPI, which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer.
Detailed description
Subjects will be randomized centrally to treatment with picoplatin administered either every two or every four weeks and will be assigned a dose of picoplatin dependent on the study results to date. Each patient will also receive therapy every two weeks with 5-FU and leucovorin. In each schedule, the cohort size will be 3 subjects, to be expanded to 6 subjects if a dose-limiting toxicity is observed. If not dose-limiting toxicity observed among the 3 subjects within a cohort, picoplatin dose escalation may proceed, until the maximum tolerated dose is established.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: (FOLPI) Picoplatin with 5-FU and Leucovorin, Drug: FOLPIPicoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion. |
| 2 | Active comparator | Drug: FOLFOXFOLFOX Oxaliplatin 85 mg/m2, as a 2-hour infusion Leucovorin (400 mg/m2 in D5W) and Oxaliplatin. Leucovorin + oxaliplatin will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Metastatic disease consistent with colorectal adenocarcinoma. Stage M1, and not amenable to curative surgery. Subjects with only locally persistent or only locally recurrent disease are not eligible.
- No prior systemic therapy for metastatic cancer. Prior adjuvant chemotherapy with a 5-FU-based treatment regimen not containing oxaliplatin or irinotecan is acceptable after a treatment-free interval of at least 6 months.
- ECOG performance score (PS) of 0 or 1.
- Life expectancy more than 3 months.
Key exclusion criteria (10 listed)
- Concurrent use of EGFR inhibitors or anti-VEGF agents.
- No clinically significant obstructive symptoms or intestinal bleeding.
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g. Crohn's disease, ulcerative colitis, malabsorption syndrome, Grade 2+ diarrhea of any etiology at baseline).
- History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
- Clinical evidence of brain metastases or central nervous system disease.
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 |
|---|---|---|
| (FOLPI) Picoplatin with 5-FU and LeucovorinPicoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion. | Drug | 1 |
| FOLPIPicoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion. | Drug | 1 |
| FOLFOXOxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion. | Drug | 2 |
Primary outcome
dose-limiting toxicity
Time frame: within the first four weeks of treatment
maximum tolerated dose
Time frame: within the first two cycles of treatment
1 secondary outcome
safety and efficacy
Time frame: duration of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
- Background: PubMed 12645909Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
- Background: PubMed 12671715Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
- Background: PubMed 9815598Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74.
- Background: PubMed 9474239Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
- Background: PubMed 9472630Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
- Background: PubMed 12142057Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
- Background: PubMed 12441268Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
- Background: PubMed 15292710Plasencia C, Abad A, Martinez-Balibrea E, Taron M. Antiproliferative effects of ZD0473 (AMD473) in combination with 5-fluorouracil or SN38 in human colorectal cancer cell lines. Invest New Drugs. 2004 Nov;22(4):399-409. doi: 10.1023/B:DRUG.0000036682.99818.71.
- Background: PubMed 12645906Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0.
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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.
Robert Earhart, MD, PhD study director
Poniard Pharmaceuticals
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing (FOLPI) Picoplatin with 5-FU and Leucovorin, FOLPI and FOLFOX in people with Colorectal Cancer, run by Poniard Pharmaceuticals at 16 sites in Russia.
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 17 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia. 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?
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?
dose-limiting toxicity (time frame: within the first four weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478946, which also lists 9 linked publications.
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 21 Jan 2009.