NeoplasmsPhase 1NCT00678132
AZD2281 and Cisplatin Plus Gemcitabine to Treat Solid Tumor Cancers
A Phase 1 study testing AZD 2281, Cisplatin and Gemcitabine in people with Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process. Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- AZD 2281, Cisplatin and Gemcitabine
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2008to 23 Nov 2010
- 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
- Patients must have histologically confirmed (by the NIH pathology department) solid tumor malignancy that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit.
- To minimize the risk of bone marrow toxicity in this population, patients must have had no more than two prior severely myelosuppressive cytotoxic chemotherapy regimens.
- Any prior therapy must have been completed greater than 2 weeks prior to enrollment on the protocol in patients participating in a phase 0 (eIND]) study, or greater than or equal to 4 weeks in patients participating in a regulatory IND study, and the participants must have recovered to eligibility levels (CTCAE Grade less than or equal to 1) from prior toxicity. Prior radiation or surgery should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (prior irradiated tumors will be considered for biopsy if signs of disease progression are present).
- Age greater than or equal to18 years. Because no dosing or AE data are currently available on the use of AZD2281 in patients less than 18 years of age, children are excluded from this study, but may be eligible for future pediatric Phase I combination trials.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60 percent).
- Life expectancy greater than or equal to 3 months.
Show all 17Show fewer
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count greater than or equal to 1,500/microL
- Platelets greater than or equal to 100,000/microL
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 times institutional upper limit of normal
- Creatinine less than or equal to 1.5 times institutional upper limit of normal
- OR
- Creatinine clearance greater than or equal to 60 mL/minute for patients with creatinine levels greater than 1.5 times institutional upper limit of normal.
- The effects of AZD2281 on the developing human fetus are unknown. For this reason, and because cisplatin and gemcitabine used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients who have previously received cisplatin or gemcitabine, or both, are eligible to enter the trial.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from AEs due to agents administered more than 4 weeks earlier. Patients must be greater than or equal to 2 weeks since any investigational agent was administered as part of an exploratory IND study and should have recovered to eligibility levels from any toxicity.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, prolonged QTc interval (greater than 500 msec), or psychiatric illness/social situations that would limit compliance with study requirements.
- In the Food and Drug Administration (FDA) Use-in-Pregnancy Ratings for Drugs, cisplatin and gemcitabine are classified as category D drugs, indicating that investigational or postmarketing data show risk to the fetus. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is a risk for AEs in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued while the patient is on this trial and for 30 days after completion of treatment on this trial.
- Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status remains stable for greater than or equal to 1 month after treatment of the brain metastases without steroids (except for maintenance replacement doses of steroids) or anti-seizure medications.
- Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded from this trial.
- Patients with lymphomas and primary CNS malignancies are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors
Background:
- AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process.
- Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers.
Read more
Objectives:
- To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that can safely be given to patients with solid tumor cancers.
- To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.
Eligibility:
-Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments are not effective.
Design:
- In this dose escalation study, the first small group of patients receives the smallest study doses of the study drugs. Subsequent groups receive incrementally higher doses as long as the preceding group does not experience unacceptable side effects. When the highest safe dose is determined, additional patients entering the study receive that dose.
- Patients receive treatment in 21-day cycles as follows:
- Days 1-4: AZD2281 by mouth twice a day
- Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1 hour.
- Day 10: gemcitabine through a vein over 1 hour.
- Evaluations during treatment include the following:
- Physical examination, vital signs check and blood tests every 3 weeks.
- CT scans every 6 weeks to evaluate the tumor.
- Treatment may continue until it is no longer beneficial.
Read the detailed description
Background:
- Poly (ADP-ribose) polymerase-enzyme (PARP-1) recognizes and rapidly binds to DNA single- and double-strand breaks and has been shown to participate in other DNA-related functions, including gene amplification, cell division, differentiation, apoptosis, and DNA base-excision repair.
- Increased PARP activity is one of the mechanisms by which tumor cells avoid apoptosis caused by DNA damaging agents, and drug resistance has been linked to higher expressions of PARP in cancer cells. This differential expression of PARP supports the observed selectivity of PARP inhibitors to affect proliferating tumor cells. AZD2281 is an orally administered potent inhibitor of PARP-1 and PARP-2, and its combination with cisplatin and gemcitabine may overcome some of the resistance associated with these agents.
Primary Objectives:
- Establish the safety, tolerability, and maximum tolerated dose (MTD) of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors.
- Evaluate the effect of cisplatin-gemcitabine, with or without AZD2281, on PAR and gamma- H2AX levels in tumor biopsies and peripheral blood mononuclear cells (PBMCs) pre- and post-treatment.
Secondary Objectives:
- Evaluate the pharmacokinetics (PK) of AZD2281 with and without cisplatin and gemcitabine.
Eligibility:
- Patients (greater than or equal to 18 years) must have histologically confirmed solid tumor malignancy that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit.
- Patients who have previously received cisplatin or gemcitabine, or both, are eligible.
Design:
- Cycle 1 and subsequent cycles: AZD2281 will be administered orally every 12 hours (Q 12 hours) on day 1, while gemcitabine will be administered intravenously (IV) over 1 hour (600 mg/m(2)/hour) on day 1 and 8 of each cycle and cisplatin over 1 hour on day 1 after gemcitabine.
- Dose escalation will proceed in cohorts of 3 6 patients to a minimum of 27 and a maximum of 42 patients.
- Patients will have a maximum of six cycles of treatment.
- Tumor biopsies will be collected in cycle 1 only, while blood for PBMC samples will be collected in cycle 1 and before drug administration, 24 and 48 hours post administration, in cycle 2, day 1. If Dose Level 3 is achieved additional time points will be collected in cycle 1, day 8 - before drug administration, 6, 24 and 48 hours post.
- Conditions
- Neoplasms
- Being tested
- AZD 2281, Cisplatin, Gemcitabine
- Keywords
- PARP Inhibitor, Combination Study, Chemotherapy, Advanced Cancer, Neoplasms, Cancer, Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD 2281Drug
CisplatinDrug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the safety and tolerability of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors. Establish the maximum tolerated dose (MTD) for the combination of AZD2281 with cisplation and gemcitabine.
Secondary outcomes (1)
Evaluate the effect of chemotherapy (cisplatin-gemcitabine) with or without AZD2281 on PAR levels and g-H2AX levels in tumor biopsies and peripheral blood mononuclear cells (PBMCs) pre- and post treatment. Evaluate the pharmacokinetic (PK) of A.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study start24 Apr 2008
- Primary completion23 Nov 2010
- Study completion23 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Giuseppe Giaccone, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678132
- Sponsor's protocol ID
- 080128
- Other IDs
- 08-C-0128
- Status last verified
- 7 Sep 2012
- First submitted
- 13 May 2008
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Ame JC, Spenlehauer C, de Murcia G. The PARP superfamily. Bioessays. 2004 Aug;26(8):882-93. doi: 10.1002/bies.20085.
PubMed 15273990D'Amours D, Desnoyers S, D'Silva I, Poirier GG. Poly(ADP-ribosyl)ation reactions in the regulation of nuclear functions. Biochem J. 1999 Sep 1;342 ( Pt 2)(Pt 2):249-68.
PubMed 10455009d'Adda di Fagagna F, Hande MP, Tong WM, Lansdorp PM, Wang ZQ, Jackson SP. Functions of poly(ADP-ribose) polymerase in controlling telomere length and chromosomal stability. Nat Genet. 1999 Sep;23(1):76-80. doi: 10.1038/12680.
PubMed 10471503Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10.
PubMed 22248721
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors
- ClinicalTrials.gov ID
- NCT00678132
- Acronym / sponsor ID
- 080128
- Conditions
- Neoplasms
- Keywords
- PARP Inhibitor, Combination Study, Chemotherapy, Advanced Cancer, Neoplasms, Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Apr 2008
- Primary completion
- 23 Nov 2010 (actual)
- Study completion
- 23 Nov 2010 (actual)
- First posted
- 15 May 2008 (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.
Background:
- AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process.
- Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers.
Objectives:
- To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that can safely be given to patients with solid tumor cancers.
- To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.
Eligibility:
-Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments are not effective.
Design:
- In this dose escalation study, the first small group of patients receives the smallest study doses of the study drugs. Subsequent groups receive incrementally higher doses as long as the preceding group does not experience unacceptable side effects. When the highest safe dose is determined, additional patients entering the study receive that dose.
- Patients receive treatment in 21-day cycles as follows:
- Days 1-4: AZD2281 by mouth twice a day
- Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1 hour.
- Day 10: gemcitabine through a vein over 1 hour.
- Evaluations during treatment include the following:
- Physical examination, vital signs check and blood tests every 3 weeks.
- CT scans every 6 weeks to evaluate the tumor.
- Treatment may continue until it is no longer beneficial.
Detailed description
Background:
- Poly (ADP-ribose) polymerase-enzyme (PARP-1) recognizes and rapidly binds to DNA single- and double-strand breaks and has been shown to participate in other DNA-related functions, including gene amplification, cell division, differentiation, apoptosis, and DNA base-excision repair.
- Increased PARP activity is one of the mechanisms by which tumor cells avoid apoptosis caused by DNA damaging agents, and drug resistance has been linked to higher expressions of PARP in cancer cells. This differential expression of PARP supports the observed selectivity of PARP inhibitors to affect proliferating tumor cells. AZD2281 is an orally administered potent inhibitor of PARP-1 and PARP-2, and its combination with cisplatin and gemcitabine may overcome some of the resistance associated with these agents.
Primary Objectives:
- Establish the safety, tolerability, and maximum tolerated dose (MTD) of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors.
- Evaluate the effect of cisplatin-gemcitabine, with or without AZD2281, on PAR and gamma- H2AX levels in tumor biopsies and peripheral blood mononuclear cells (PBMCs) pre- and post-treatment.
Secondary Objectives:
- Evaluate the pharmacokinetics (PK) of AZD2281 with and without cisplatin and gemcitabine.
Eligibility:
- Patients (greater than or equal to 18 years) must have histologically confirmed solid tumor malignancy that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit.
- Patients who have previously received cisplatin or gemcitabine, or both, are eligible.
Design:
- Cycle 1 and subsequent cycles: AZD2281 will be administered orally every 12 hours (Q 12 hours) on day 1, while gemcitabine will be administered intravenously (IV) over 1 hour (600 mg/m(2)/hour) on day 1 and 8 of each cycle and cisplatin over 1 hour on day 1 after gemcitabine.
- Dose escalation will proceed in cohorts of 3 6 patients to a minimum of 27 and a maximum of 42 patients.
- Patients will have a maximum of six cycles of treatment.
- Tumor biopsies will be collected in cycle 1 only, while blood for PBMC samples will be collected in cycle 1 and before drug administration, 24 and 48 hours post administration, in cycle 2, day 1. If Dose Level 3 is achieved additional time points will be collected in cycle 1, day 8 - before drug administration, 6, 24 and 48 hours post.
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 (17 listed)
- Patients must have histologically confirmed (by the NIH pathology department) solid tumor malignancy that is metastatic or unresectable for which standard curative measures do not exist, or are associated with minimal patient survival benefit.
- To minimize the risk of bone marrow toxicity in this population, patients must have had no more than two prior severely myelosuppressive cytotoxic chemotherapy regimens.
- Any prior therapy must have been completed greater than 2 weeks prior to enrollment on the protocol in patients participating in a phase 0 (eIND]) study, or greater than or equal to 4 weeks in patients participating in a regulatory IND study, and the participants must have recovered to eligibility levels (CTCAE Grade less than or equal to 1) from prior toxicity. Prior radiation or surgery should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (prior irradiated tumors will be considered for biopsy if signs of disease progression are present).
- Age greater than or equal to18 years. Because no dosing or AE data are currently available on the use of AZD2281 in patients less than 18 years of age, children are excluded from this study, but may be eligible for future pediatric Phase I combination trials.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60 percent).
Key exclusion criteria (6 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from AEs due to agents administered more than 4 weeks earlier. Patients must be greater than or equal to 2 weeks since any investigational agent was administered as part of an exploratory IND study and should have recovered to eligibility levels from any toxicity.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, prolonged QTc interval (greater than 500 msec), or psychiatric illness/social situations that would limit compliance with study requirements.
- In the Food and Drug Administration (FDA) Use-in-Pregnancy Ratings for Drugs, cisplatin and gemcitabine are classified as category D drugs, indicating that investigational or postmarketing data show risk to the fetus. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is a risk for AEs in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued while the patient is on this trial and for 30 days after completion of treatment on this trial.
- Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status remains stable for greater than or equal to 1 month after treatment of the brain metastases without steroids (except for maintenance replacement doses of steroids) or anti-seizure medications.
- Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded from this trial.
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 |
|---|---|---|
| AZD 2281 | Drug | – |
| Cisplatin | Drug | – |
| Gemcitabine | Drug | – |
Primary outcome
Establish the safety and tolerability of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors. Establish the maximum tolerated dose (MTD) for the combination of AZD2281 with cisplation and gemcitabine.
1 secondary outcome
Evaluate the effect of chemotherapy (cisplatin-gemcitabine) with or without AZD2281 on PAR levels and g-H2AX levels in tumor biopsies and peripheral blood mononuclear cells (PBMCs) pre- and post treatment. Evaluate the pharmacokinetic (PK) of A.
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 5 Jul 2018.
- Background: PubMed 15273990Ame JC, Spenlehauer C, de Murcia G. The PARP superfamily. Bioessays. 2004 Aug;26(8):882-93. doi: 10.1002/bies.20085.
- Background: PubMed 10455009D'Amours D, Desnoyers S, D'Silva I, Poirier GG. Poly(ADP-ribosyl)ation reactions in the regulation of nuclear functions. Biochem J. 1999 Sep 1;342 ( Pt 2)(Pt 2):249-68.
- Background: PubMed 10471503d'Adda di Fagagna F, Hande MP, Tong WM, Lansdorp PM, Wang ZQ, Jackson SP. Functions of poly(ADP-ribose) polymerase in controlling telomere length and chromosomal stability. Nat Genet. 1999 Sep;23(1):76-80. doi: 10.1038/12680.
- Derived from this study: PubMed 22248721Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10.
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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.
Giuseppe Giaccone, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD 2281, Cisplatin and Gemcitabine in people with Neoplasms, run by National Cancer Institute (NCI) at 1 site 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 17 inclusion and 6 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Establish the safety and tolerability of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors. Establish the maximum tolerated dose (MTD) for the combination of AZD2281 with cisplation and gemcitabine.. 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 NCT00678132, which also lists 4 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 5 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.