Wilms' TumorPhase 1NCT00011414
Phase I Trial of Tariquidar (XR9576) in Combination With Doxorubicin, Vinorelbine, or Docetaxel in Pediatric Patients With Solid Tumors
A Phase 1 study testing Tariquidar in people with Wilms' Tumor and Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will evaluate the tolerance and effects of tariquidar, given in combination with one of three anticancer drugs, for treating solid tumors. Tariquidar works by blocking a pump on a cancer cell. The pump on a cell that prevents anticancer drugs from accumulating is called Pgp (P-glycoprotein). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Wilms' Tumor, Sarcoma, Adenaocortical Carcinoma
- What is being tested?
- Tariquidar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2001to 13 Jan 2016
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: Patients must be greater than or equal to 2 and less than or equal to 18 years of age.
- Diagnosis: Histologically confirmed solid tumors which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, and primary brain tumors. In patients with brain stem or optic gliomas the requirement for histological confirmation may be waived.
- Measurable/Evaluable Disease: Patients must have measurable or evaluable tumors.
- Prior Therapy: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities.
- For patients receiving doxorubicin on this study, the patient must have had their last dose of radiation therapy at least four weeks prior to study entry; For patients receiving docetaxel or vinorelbine, the patient must have had their last dose of extensive radiation (craneospinal or more than 50 percent of pelvis) at least 4 weeks prior to study entry or last dose of limited field radiation (local) at least 2 weeks prior to study entry.
- Patients must have had their last dose of chemotherapy at least 21 days prior to study entry (28 days for nitrosoureas), and their last dose of any investigational cancer therapy at least 30 days prior to study entry.
Show all 19Show fewer
- Patients must have recovered from the toxic effects of all prior therapy before entry onto this trial.
- Patients with brain tumors must be on a stable or tapering dose of corticosteriods for 7 days prior to the baseline scan performed for the purpose of assessing response to therapy on this study.
- Patients should be off colony stimulating factors such as G-CSF, GM-CSF, erythropoietin, and IL-11 for at least 72 hours prior to study entry.
- Lifetime cumulative dose of anthracycline: Restrictions on the prior cumulative dose anthracylines only apply to patients who will receive doxorubicin in combination with tariquidar.
- The lifetime cumulative dose of anthracycline must be less than or equal to 300 mg/m(2) in patients who will receive doxorubicin in combination with tariquidar, if the anthracycline was administered as a bolus injection without a cardioprotectant (e.g., dexrazoxane) OR if the patient had mediastinal radiation.
- The lifetime cumulative dose of anthracycline must be less than or equal to 400 mg/m(2), if the anthracycline was administered by continuous infusion or with a cardioprotectant and the patient has not had mediastinal radiation.
- Performance Status: Patients should have an ECOG performance status of 0,1, or 2. Patients who unable to walk because of paralysis or weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
- Hematologic Function: Patients must have adequate bone marrow function, defined as a peripheral absolute granulocyte count of greater than or equal to 1,500/microL, hemoglobin greater than or equal to 8 gm/dL, and a platelet count greater than or equal to 100,000/microL.
- Hepatic Function: Patients must have adequate liver function, defined as bilirubin within normal limits, SGPT (ALT) less than 2x the upper limit of normal.
- Renal Function: Patients must have an age-adjusted normal serum creatinine OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2).
- Cardiac Function: Patients who will receive doxorubicin must have normal cardiac ejection fraction by echocardiogram. An echocardiogram does not need to be performed in patients who will receive docetaxel or vinorelbine.
- Informed Consent: All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. (This does not include routine laboratory tests or imaging studies required to establish eligibility).
- Durable Power of Attorney (DPA): Patients who have brain tumors and who are greater than or equal to 18 years of age will be offered the opportunity to assign a DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired.
Who cannot join
- Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgement of the Principle or Associate Investigator would compromise the patient's ability to tolerate and of the agents in this trial or are likely to interfere with the study procedures or results.
- Patients with a history of bone marrow transplantation within the previous 4 months or extensive radiotherapy (craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) within the previous 4 months.
- Pregnant or breast feeding females are excluded because tariquidar in combination with a cytotoxic drug may be harmful to the developing fetus or nursing child.
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: Phase I Trial and Pharmacokinetic Study of Tariquidar (XR9576), a P-Glycoprotein Inhibitor, in Combination With Doxorubicin, Vinorelbine or Docetaxel in Pediatric Patients With Refractory Solid Tumors Including Brain Tumors
This study will evaluate the tolerance and effects of tariquidar, given in combination with one of three anticancer drugs, for treating solid tumors. Tariquidar works by blocking a pump on a cancer cell. The pump on a cell that prevents anticancer drugs from accumulating is called Pgp (P-glycoprotein). Researchers hope to see whether cancer-fighting drugs can stay in the cells longer.
Patients ages 2 to 18 who have solid tumors may be eligible for this study. Tariquidar is infused intravenously (IV) over 30 minutes, given every 21 to 28 days, with one drug that kills cancer cells. Patients are examined by a doctor at least once weekly during treatment and will have routine blood tests twice weekly. They will receive one of the following drugs with tariquidar: doxorubicin (Adriamycin ), vinorelbine (Navelbine ), or docetaxel (Taxotere ). At the first treatment cycle only, there is a baseline Sestamibi scan before treatment and a second one immediately after drug administration. If patients receive tariquidar with doxorubicin, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, followed by doxorubicin by IV over 15 minutes. Dexrazoxane, which decreases damaging effects of doxorubicin on the heart, is also given by IV over 15 minutes. Granulocyte colony stimulating factor (G-CSF) is injected daily 48 hours after doxorubicin, to alleviate doxorubicin s effect on white blood cells. If patients receive tariquidar with vinorelbine, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, immediately followed by vinorelbine by IV over 10 minutes; then 1 week later, tariquidar is again given, immediately followed by vinorelbine by IV for 10 minutes. G-CSF is given daily. If patients receive tariquidar with docetaxel, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, followed by docetaxel by IV over 60 minutes. Drugs to prevent allergic reactions are given before and after each docetaxel dose. G-CSF is given daily.
Read more
Tariquidar may affect blood pressure during infusion, and there can be reduction of normal blood cells, gastrointestinal problems, and allergic reactions. The radioactive Sestamibi can cause headache, chest pain, and nausea. Radiation used in this study has been approved as involving a slightly greater than minimal risk for adults and an acceptable risk for children. This radiation is considered necessary to obtain information desired. One possible effect is a slight increase in the risk of cancer.
This study may or may not have a direct benefit for participants. However, knowledge gained may benefit people with cancer in the future.
Read the detailed description
Background:
- Pgp is a 170 kDa plasma membrane glycoprotein that functions as a non-specific energy-dependent drug efflux pump. Pgp is expressed in a variety of normal human tissues, such as renal proximal tubules, capillary endothelial cells that comprise the blood-brain barrier, epithelial cells lining the bile canaliculi, bone marrow stem cells, and peripherial blood mononuclear cells.
- Pgp over-expression in tumor cells results in a multidrug resistance phenotype by preventing the intracellular accumulation of a variety of chemotherapeutic agents, including anthracyclines, taxanes, vinca alkyloids, and epipodophyllotoxins. Inhibition of Pgp may partially reverse multidrug resistance by increasing intracellular drug accumulation in tumor cells.
- Tariquidar (XR9576) is a specific Pgp inhibitor that blocks Pgp function for up to 24 hours after a single dose without significant toxicity in animals and humans.
- In adults, tariquidar in combination with doxorubicin, paxlitaxel, or vinorelbine is well tolerated, and only minor alterations in the clearance and drug exposure (area under the concentration time curve, AUC) of the anticancer drugs have been observed.
Objectives:
- Study the tolerance and toxicity profile of tariquidar at three dose levels in combination with one of three anticancer drugs (doxorubicin, docetaxel, vinorelbine) in pediatric patients with refractory solid tumors including brain tumors.
- Define the maximum tolerated dose of tariquidar in children if dose-limiting toxicity is observed at doses less than or equal to 2 mg/kg.
- Study the pharmacokinetics of tariquidar alone and in combination with doxorubicin, docetaxel or vinorelbine in pediatric patients.
- Study the pharmacodynamics (effect on Pgp function) of tariquidar ex vivo in peripheral blood mononuclear cells (CD56+) with a rhodamine uptake assay and in vivo in tissues and tumor by (99m) Tc-sestamibi scan.
- Study alterations in the acute toxicity and pharmacokinetic profile of doxorubicin, vinorelbine or docetaxel when administered in combination with tariquidar.
- When possible, assess Pgp expression in tumor specimens by immunohistochemistry and compare immunohistochemisty results with in vivo Pgp functional studies (99m) Tc-sestamibi scan).
Eligibility:
-Children and adolescents (greater than or equal to 2 years and less than or equal to 18 years of age) with histologically confirmed relapsed or refractory solid tumors that are measureable or evaluable.
Design:
- Tariquidar will be administered alone and in combination with doxorubicin, vinorelbine, or doctaxel. Tariquidar dose levels will be 1, 1.5, and 2 mg/kg. Intrapatient dose escalation of tariquidar is permitted.
- Detailed pharmacokinetic and pharmacodynamic studies are performed in cycle 1.
- The trial follows a standard phase 1 design with 3 to 6 patients per dose level. At the recommedmed dose of tariquidar, 6 patients will be enrolled with each cytotoxic agent. Up to 36 patients will be entered on this trial.
- Being tested
- Tariquidar
- Keywords
- Drug Resistance, PEDIATRIC SOLID TUMORS, Chemotherapy, p-glycoprotien, Brain Tumors, Childhood Cancer, Brain Tumor
- Medical subject headings
- Wilms Tumor, Sarcoma, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TariquidarDrug
IV alone for 1 dose (Day -1), then in combo for rest of cycle (Day 1, etc). Given in combo with one of the following: Doxorubicin (50 mg/m2 IV over 15 min on day 1), Vinorelbine (20 mg/m2 IV over 10 min on days 1 and 8), or Docetaxel (75 mg/m2 IV over 60 min on day 1).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention given with dose escalation of tariquidar Receives: Drug: Tariquidar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance and toxicity profile
Measured: 1.5 years
MTD
Measured: 1.5 years
Pharmacokinetics alone & in combination
Measured: 2 years
Pharmacodynamics ex vivo
Measured: 3 years
Secondary outcomes (3)
Alterations in the acute toxicity profile of doxorubicin, vinorelbine or docetaxel when with tariquidar
Measured: 1.5 years
Alterations in plasma pharmacokinetics of doxorubicin, vinorelbine, ordocetaxel when with tariquidar
Measured: 2 years
Assess Pgp expression in tumor specimens
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2001 (estimated)
- Study start15 Feb 2001
- Primary completion28 Nov 2007
- Study completion13 Jan 2016
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 Wilms' TumorStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brigitte C Widemann, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011414
- Sponsor's protocol ID
- 010091
- Other IDs
- 01-C-0091
- Status last verified
- 13 Jan 2016
- First submitted
- 17 Feb 2001
- Last updated
- 16 Jul 2019
- Results posted
- No
Publications
Arceci RJ. Clinical significance of P-glycoprotein in multidrug resistance malignancies. Blood. 1993 May 1;81(9):2215-22. No abstract available.
PubMed 8097632Bradshaw DM, Arceci RJ. Clinical relevance of transmembrane drug efflux as a mechanism of multidrug resistance. J Clin Oncol. 1998 Nov;16(11):3674-90. doi: 10.1200/JCO.1998.16.11.3674.
PubMed 9817290Deuchars KL, Ling V. P-glycoprotein and multidrug resistance in cancer chemotherapy. Semin Oncol. 1989 Apr;16(2):156-65. No abstract available.
PubMed 2565605Fox E, Widemann BC, Pastakia D, Chen CC, Yang SX, Cole D, Balis FM. Pharmacokinetic and pharmacodynamic study of tariquidar (XR9576), a P-glycoprotein inhibitor, in combination with doxorubicin, vinorelbine, or docetaxel in children and adolescents with refractory solid tumors. Cancer Chemother Pharmacol. 2015 Dec;76(6):1273-83. doi: 10.1007/s00280-015-2845-1. Epub 2015 Oct 20.
PubMed 26486517
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial and Pharmacokinetic Study of Tariquidar (XR9576), a P-Glycoprotein Inhibitor, in Combination With Doxorubicin, Vinorelbine or Docetaxel in Pediatric Patients With Refractory Solid Tumors Including Brain Tumors
- ClinicalTrials.gov ID
- NCT00011414
- Acronym / sponsor ID
- 010091
- Keywords
- Drug Resistance, PEDIATRIC SOLID TUMORS, Chemotherapy, p-glycoprotien, Brain Tumors, Childhood Cancer, Brain Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 Feb 2001
- Primary completion
- 28 Nov 2007 (actual)
- Study completion
- 13 Jan 2016 (actual)
- First posted
- 19 Feb 2001 (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 study will evaluate the tolerance and effects of tariquidar, given in combination with one of three anticancer drugs, for treating solid tumors. Tariquidar works by blocking a pump on a cancer cell. The pump on a cell that prevents anticancer drugs from accumulating is called Pgp (P-glycoprotein). Researchers hope to see whether cancer-fighting drugs can stay in the cells longer.
Patients ages 2 to 18 who have solid tumors may be eligible for this study. Tariquidar is infused intravenously (IV) over 30 minutes, given every 21 to 28 days, with one drug that kills cancer cells. Patients are examined by a doctor at least once weekly during treatment and will have routine blood tests twice weekly. They will receive one of the following drugs with tariquidar: doxorubicin (Adriamycin ), vinorelbine (Navelbine ), or docetaxel (Taxotere ). At the first treatment cycle only, there is a baseline Sestamibi scan before treatment and a second one immediately after drug administration. If patients receive tariquidar with doxorubicin, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, followed by doxorubicin by IV over 15 minutes. Dexrazoxane, which decreases damaging effects of doxorubicin on the heart, is also given by IV over 15 minutes. Granulocyte colony stimulating factor (G-CSF) is injected daily 48 hours after doxorubicin, to alleviate doxorubicin s effect on white blood cells. If patients receive tariquidar with vinorelbine, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, immediately followed by vinorelbine by IV over 10 minutes; then 1 week later, tariquidar is again given, immediately followed by vinorelbine by IV for 10 minutes. G-CSF is given daily. If patients receive tariquidar with docetaxel, tariquidar is given alone. Then 48 to 72 hours later, the second dose is given, followed by docetaxel by IV over 60 minutes. Drugs to prevent allergic reactions are given before and after each docetaxel dose. G-CSF is given daily.
Tariquidar may affect blood pressure during infusion, and there can be reduction of normal blood cells, gastrointestinal problems, and allergic reactions. The radioactive Sestamibi can cause headache, chest pain, and nausea. Radiation used in this study has been approved as involving a slightly greater than minimal risk for adults and an acceptable risk for children. This radiation is considered necessary to obtain information desired. One possible effect is a slight increase in the risk of cancer.
This study may or may not have a direct benefit for participants. However, knowledge gained may benefit people with cancer in the future.
Detailed description
Background:
- Pgp is a 170 kDa plasma membrane glycoprotein that functions as a non-specific energy-dependent drug efflux pump. Pgp is expressed in a variety of normal human tissues, such as renal proximal tubules, capillary endothelial cells that comprise the blood-brain barrier, epithelial cells lining the bile canaliculi, bone marrow stem cells, and peripherial blood mononuclear cells.
- Pgp over-expression in tumor cells results in a multidrug resistance phenotype by preventing the intracellular accumulation of a variety of chemotherapeutic agents, including anthracyclines, taxanes, vinca alkyloids, and epipodophyllotoxins. Inhibition of Pgp may partially reverse multidrug resistance by increasing intracellular drug accumulation in tumor cells.
- Tariquidar (XR9576) is a specific Pgp inhibitor that blocks Pgp function for up to 24 hours after a single dose without significant toxicity in animals and humans.
- In adults, tariquidar in combination with doxorubicin, paxlitaxel, or vinorelbine is well tolerated, and only minor alterations in the clearance and drug exposure (area under the concentration time curve, AUC) of the anticancer drugs have been observed.
Objectives:
- Study the tolerance and toxicity profile of tariquidar at three dose levels in combination with one of three anticancer drugs (doxorubicin, docetaxel, vinorelbine) in pediatric patients with refractory solid tumors including brain tumors.
- Define the maximum tolerated dose of tariquidar in children if dose-limiting toxicity is observed at doses less than or equal to 2 mg/kg.
- Study the pharmacokinetics of tariquidar alone and in combination with doxorubicin, docetaxel or vinorelbine in pediatric patients.
- Study the pharmacodynamics (effect on Pgp function) of tariquidar ex vivo in peripheral blood mononuclear cells (CD56+) with a rhodamine uptake assay and in vivo in tissues and tumor by (99m) Tc-sestamibi scan.
- Study alterations in the acute toxicity and pharmacokinetic profile of doxorubicin, vinorelbine or docetaxel when administered in combination with tariquidar.
- When possible, assess Pgp expression in tumor specimens by immunohistochemistry and compare immunohistochemisty results with in vivo Pgp functional studies (99m) Tc-sestamibi scan).
Eligibility:
-Children and adolescents (greater than or equal to 2 years and less than or equal to 18 years of age) with histologically confirmed relapsed or refractory solid tumors that are measureable or evaluable.
Design:
- Tariquidar will be administered alone and in combination with doxorubicin, vinorelbine, or doctaxel. Tariquidar dose levels will be 1, 1.5, and 2 mg/kg. Intrapatient dose escalation of tariquidar is permitted.
- Detailed pharmacokinetic and pharmacodynamic studies are performed in cycle 1.
- The trial follows a standard phase 1 design with 3 to 6 patients per dose level. At the recommedmed dose of tariquidar, 6 patients will be enrolled with each cytotoxic agent. Up to 36 patients will be entered on this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TariquidarIntervention given with dose escalation of tariquidar |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Age: Patients must be greater than or equal to 2 and less than or equal to 18 years of age.
- Diagnosis: Histologically confirmed solid tumors which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, and primary brain tumors. In patients with brain stem or optic gliomas the requirement for histological confirmation may be waived.
- Measurable/Evaluable Disease: Patients must have measurable or evaluable tumors.
- Prior Therapy: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities.
- For patients receiving doxorubicin on this study, the patient must have had their last dose of radiation therapy at least four weeks prior to study entry; For patients receiving docetaxel or vinorelbine, the patient must have had their last dose of extensive radiation (craneospinal or more than 50 percent of pelvis) at least 4 weeks prior to study entry or last dose of limited field radiation (local) at least 2 weeks prior to study entry.
Key exclusion criteria (3 listed)
- Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgement of the Principle or Associate Investigator would compromise the patient's ability to tolerate and of the agents in this trial or are likely to interfere with the study procedures or results.
- Patients with a history of bone marrow transplantation within the previous 4 months or extensive radiotherapy (craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) within the previous 4 months.
- Pregnant or breast feeding females are excluded because tariquidar in combination with a cytotoxic drug may be harmful to the developing fetus or nursing child.
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 |
|---|---|---|
| TariquidarIV alone for 1 dose (Day -1), then in combo for rest of cycle (Day 1, etc). Given in combo with one of the following: Doxorubicin (50 mg/m2 IV over 15 min on day 1), Vinorelbine (20 mg/m2 IV over 10 min on days 1 and 8), or Docetaxel (75 mg/m2 IV over 60 min on day 1). | Drug | 1 |
Primary outcome
Tolerance and toxicity profile
Time frame: 1.5 years
MTD
Time frame: 1.5 years
Pharmacokinetics alone & in combination
Time frame: 2 years
Pharmacodynamics ex vivo
Time frame: 3 years
3 secondary outcomes
Alterations in the acute toxicity profile of doxorubicin, vinorelbine or docetaxel when with tariquidar
Time frame: 1.5 years
Alterations in plasma pharmacokinetics of doxorubicin, vinorelbine, ordocetaxel when with tariquidar
Time frame: 2 years
Assess Pgp expression in tumor specimens
Time frame: 3 years
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 16 Jul 2019.
- Background: PubMed 8097632Arceci RJ. Clinical significance of P-glycoprotein in multidrug resistance malignancies. Blood. 1993 May 1;81(9):2215-22. No abstract available.
- Background: PubMed 9817290Bradshaw DM, Arceci RJ. Clinical relevance of transmembrane drug efflux as a mechanism of multidrug resistance. J Clin Oncol. 1998 Nov;16(11):3674-90. doi: 10.1200/JCO.1998.16.11.3674.
- Background: PubMed 2565605Deuchars KL, Ling V. P-glycoprotein and multidrug resistance in cancer chemotherapy. Semin Oncol. 1989 Apr;16(2):156-65. No abstract available.
- Derived from this study: PubMed 26486517Fox E, Widemann BC, Pastakia D, Chen CC, Yang SX, Cole D, Balis FM. Pharmacokinetic and pharmacodynamic study of tariquidar (XR9576), a P-glycoprotein inhibitor, in combination with doxorubicin, vinorelbine, or docetaxel in children and adolescents with refractory solid tumors. Cancer Chemother Pharmacol. 2015 Dec;76(6):1273-83. doi: 10.1007/s00280-015-2845-1. Epub 2015 Oct 20.
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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.
Brigitte C Widemann, 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 Tariquidar in people with Wilms' Tumor and Sarcoma, 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 19 inclusion and 3 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 16 Jul 2019. 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?
Tolerance and toxicity profile (time frame: 1.5 years). The study lists 4 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 NCT00011414, 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 16 Jul 2019.