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Advanced CancerPhase 1NCT00429234

Gemcitabine and Dasatinib in Advanced Solid Tumors

A Phase 1 study testing Dasatinib and Gemcitabine in people with Advanced Cancer and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical research study is to find the highest tolerable dose of dasatinib in combination with gemcitabine that can be given to patients with advanced solid tumors. The safety of this combination of study drugs will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Solid Tumors
What is being tested?
Dasatinib and Gemcitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Jan 2007to Feb 2013
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

  • Signed written informed consent
  • Available for protocol-required follow-up
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
  • Histologic or cytologic diagnosis of a primary solid malignancy
  • Evidence (radiographic or tissue confirmation) that the disease is metastatic, or locally advanced in patients who are not candidates for standard therapy
  • Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
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  • Adequate bone marrow function defined as: a) absolute neutrophil count (neutrophil and bands) >/= 1,500 cells/mm^3, b) platelet count >/= 100,000 cells/mm^3, c) hemoglobin >/= 9.0 g/dl
  • Adequate hepatic function defined as: a) total bilirubin </= 1.5 times the institutional upper limit upper limit of normal (ULN), b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.0 times the institutional ULN, c) Exception: patients with primary liver tumors or known liver metastases: </= 3.0 times the institutional ULN for total bilirubin, AST and ALT
  • Adequate renal function defined as serum creatinine </= 1.5 times the institutional ULN
  • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Patients with low potassium, calcium and magnesium levels may be repleted to allow for protocol entry
  • Prior chemo-, radio-, hormonal or immunotherapy are allowed. Patients must have recovered from toxicity due to prior therapy i.e., toxicity has resolved to baseline or is deemed irreversible. At least 4 weeks must have elapsed since the last chemotherapy or investigational agent (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and the beginning of protocol therapy. At least 2 weeks must have elapsed since last hormonal therapy or exposure to any other "targeted" kinase inhibitor (e.g., imatinib mesylate)
  • Men and women, ages 18 and older
  • Women of childbearing potential (WOCBP) must be using an adequate method (i.e. barrier, spermicidal) of contraception to avoid pregnancy throughout the study and for a period of at least 1 month prior and at least 3 months after the study in such a manner that the risk of pregnancy is minimized
  • Continued from inclusion #13: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >/= 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]
  • Continued from inclusion #13 and 14: Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication
  • At the MTD expansion phase of the protocol, all patients must have fine needle aspirate (FNA) biopsiable disease

Who cannot join

  • Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) to avoid pregnancy for the entire study period including the period from one month prior to starting study medication and for a period of at least 3 months after the study
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration
  • Men who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) of birth control for the entire study period and for at least 3 months after completion of study medication if their sexual partners are WOCBP
  • Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to </= 25% of bone marrow-containing skeleton
  • Symptomatic brain metastasis that are either untreated or uncontrolled by surgery and or radiotherapy. Patients with symptoms of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI and/or fully treated surgically or with whole-brain radiotherapy (WBRT)
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  • A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy
  • Uncontrolled or significant cardiovascular disease, including: a)A myocardial infarction within 6 months, b)Subjects with known symptomatic cardiomyopathy, c)Uncontrolled angina within 3 months, d)Congestive heart failure within 3 months, e)diagnosed or suspected congenital long QT syndrome, f)any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes). Prolonged QTc interval on pre-entry electrocardiogram (>450 msec). If the automated reading is prolonged (i.e.>450 msec), the ECG should be manually overread,
  • Continued from exclusion #9: g) any history of second or third degree heart block (may be eligible if currently have a pacemaker) h) heart rate < 50 / minute on pre-entry electrocardiogram or i) uncontrolled hypertension
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • History of significant bleeding disorder including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c) Documented major bleeding episode from the GI tract within 6 months, d) Vasculitis, e) Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
  • Patients who have not recovered from adverse events greater than grade 1 due to agents administered more than 4 weeks earlier
  • Prior exposure to dasatinib
  • Gastric pH modifying agents. Subjects should not take proton pump inhibitors and H2 antagonists. Short-acting antacid agents may be taken, and replaced for patients who are on gastric pH modifying agents prior to enrollment
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with myelosuppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with dasatinib or other agents administered during the study
  • Social situations that would limit compliance with study requirements
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, dasatinib, or other agents used in this study
  • Any pleural effusion felt to be clinically significant by the attending physician or principal investigator (P.I.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Open-Labeled Trial of Gemcitabine and Dasatinib in Advanced Solid Tumors

The goal of this clinical research study is to find the highest tolerable dose of dasatinib in combination with gemcitabine that can be given to patients with advanced solid tumors. The safety of this combination of study drugs will also be studied.

Researchers also want to study the pharmacodynamics (PDs) of this study drug combination. PD testing is used to learn what effect the drugs have on your tumors.

Read the detailed description

Dasatinib is designed to block several proteins that have been shown to be important for the growth, spreading, and survival of cancers cells.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause them to die and prevent further growth of cancer cells.

The amount of dasatinib and gemcitabine that you receive will depend on when you start on this study. There will be 3 participants enrolled in each group. The first group of participants enrolled on this study will be given small doses of dasatinib and gemcitabine. If no intolerable side effects are experienced, the next group of participants will be enrolled at a higher dose level. This process will continue until researchers find the highest tolerable dose of dasatinib and gemcitabine that can be given without intolerable side effects occurring. Up to 15 more patients will be enrolled at this highest tolerable dose in an expansion group. If you are enrolled in the expansion group, you will have a biopsy for PD testing prior to your first day on the study. Your doctor will tell you which group you are enrolled in.

Your study doctor will tell you what dose of dasatinib and gemcitabine you will be receiving and how it compares to the doses other participants have received. While on study, your dose may be increased to the next higher level, if the next higher dose level has already been tested in other participants and found to be tolerable.

You will take dasatinib by mouth once a day for 7 days in a row before you begin receiving gemcitabine by vein. If no intolerable side effects from dasatinib occur, you will continue taking it for the rest of the study. If you are enrolled in an expansion group, you will take dasatinib by mouth once a day for 56 days in a row.

If the disease get worse or you experience any intolerable side effects with dasatinib, you will be taken off this study before you begin taking gemcitabine.

You will receive gemcitabine by vein over 30 minutes starting on Day 8. The first cycle is 9 weeks long (63 days). You will receive gemcitabine by vein over 30 minutes once a week for 7 weeks on Days 8, 15, 22, 29, 36, 43, and 50. On Days 51-63, you will not receive any gemcitabine (a rest period for this drug), but you will continue to take dasatinib once a day. There will not be a rest period for dasatinib.

If you are enrolled in an expansion group, you will receive gemcitabine by vein over 30 minutes starting on Day 1. The first cycle is 8 weeks long (56 days). You will receive gemcitabine by vein over 30 minutes once a week for 7 weeks on Days 1, 8, 15, 22, 29, 36 and 43. On Days 44- 56, you will not receive any gemcitabine (a rest period for this drug), but you will continue to take dasatinib once a day. There will not be a rest period for dasatinib.

Cycle 2 and all other cycles will equal 28 days. You will continue to take dasatinib once a day. You will receive gemcitabine once a week for 3 weeks on Days 1, 8, and 15. On Days 16-28, you will not receive any gemcitabine, but you will continue to take dasatinib once a day.

If you experience any intolerable side effects, you may need to have additional blood drawn (about 2 teaspoons) to monitor your condition. Your dose level may be reduced to stop intolerable side effects from occurring, depending on what the study doctor thinks is best. If the disease gets worse or you continue to experience any intolerable side effects with gemcitabine, you will be taken off this study.

You will have blood drawn (about 1 teaspoon each time) for PD testing. In Cycle 1 before your daily dose of dasatinib and gemcitabine, PD blood samples will be drawn 1-4 days before you receive the study drug, on Day 8 (on the day the 1st dose of gemcitabine is given) and at the end of week 4 before your receive the study drug.

During Week 4 of Cycle 1 and at the end of Cycle 1, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 tablespoon) and urine collected (at the end of Cycle 1 only) for routine tests. You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation) and how you are feeling. You will also be asked about other drugs you may be taking and if you have had any intolerable side effects from the study drugs.

On Day 1 of all remaining cycles, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 teaspoon) for routine tests. You will have a performance status evaluation and be asked how you are feeling. You will also be asked about other drugs you may be taking and if you have had any intolerable side effects from the study drugs.

Once your participation has ended on this study for any reason, you will be asked to have an end-of-study visit that should occur about 28 days after the last dose of the study drug. At this visit, you will have a physical exam, including measurement of your vital signs and weight. You will have a performance status evaluation and be asked how you are feeling. Blood (about 1 teaspoon) and urine will be collected for routine tests. You will be asked about other drugs you may be taking, and you will be asked if you have had any intolerable side effects from the study drugs. Women who are able to have children will again have a blood (about 1 teaspoon) pregnancy test.

If there are study-related side effects reported at the end-of-study visit, you will continue to have follow-up visits or telephone calls, (which will last about 5-10 minutes each time) at least every 4 weeks, to check if you are still experiencing sides effects and until you no longer experience them.

This is an investigational study. Dasatinib and gemcitabine are both FDA approved and commercially available. Their use together in this study is experimental and authorized for use in research only. Up to 63 patients will take part in this study. All will be enrolled at M. D. Anderson.

Being tested
Dasatinib, Gemcitabine
Keywords
Advanced Cancer, Solid Tumors, Dasatinib, BMS-354825, Sprycel, Gemcitabine, Gemcitabine Hydrochloride, Gemzar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called BMS-354825, Sprycel

    Starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks.

  • GemcitabineDrug

    Also called Gemzar, Gemcitabine Hydrochloride

    Starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.

Study groups in NCT00429234
Study groupRoleWhat they receive
Dasatinib + GemcitabineExperimentalDasatinib starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks. Gemcitabine starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
Receives: Drug: Dasatinib; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated combination doses (MTD)

    Measured: 8 week cycle for Cycle 1, all other cycles 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00429234
Sponsor's protocol ID
2006-0574
Status last verified
Apr 2013
First submitted
29 Jan 2007
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dasatinib and Gemcitabine in people with Advanced Cancer and Solid Tumors, run by M.D. Anderson Cancer Center 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 19 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 4 Apr 2013. 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?

Maximum tolerated combination doses (MTD) (time frame: 8 week cycle for Cycle 1, all other cycles 28 days). 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 NCT00429234.

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 Apr 2013.

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