Solid TumorsPhase 1NCT01245543
Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid Tumors
A Phase 1 study testing AC480IV and Docetaxel in people with Solid Tumors, run by Daiichi Sankyo at 2 sites in United States.
Trial summary
AC480IV will be administered as a monotherapy and then in combination with docetaxel in patients with locally advanced or metastatic solid tumors for whom there are no standard or curative therapies available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- AC480IV and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Jun 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
- Male or female age ≥18 years
- Provide written informed consent
- Has histological diagnosis of a primary solid tumor malignancy that meets study criteria
- Has measurable disease (or evaluable if not in MTD expansion cohort) via computed tomography (CT) or magnetic resonance imaging (MRI) scans with or without non-measurable tumors (a lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of that lesion prior to enrollment)
- Less than 4 prior systemic cancer therapies (with the exception of hormonal agents), including experimental agents, prior HER-family TKI therapies, and prior docetaxel and other taxane therapy; there are no limits to the number of prior therapies for Part 1
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
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- WOCBP must have a negative serum or urine pregnancy test (sensitivity ≤ 25IU human chorionic gonadotropin [hCG]/L) within 72 hours prior to the start of study drug administration
- Has an ECOG performance status of 0 or 1
- Has a life expectancy >3 months
- Has adequate organ function as determined by laboratory tests
Who cannot join
- Patient is currently receiving or has received within the last month prior to Cycle 1 Day 1 (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin) other chemotherapeutic, hormonal, or investigational anti-cancer agents with the exception of gonadal suppression agents and bisphosphonates for osteoporosis and skeletal metastases which may be continued while on study
- Patient has received other chemotherapeutic, hormonal, or investigational anti cancer agents that are outside of the timeframe described above and thus would be allowed in the study, but has toxicity that is unresolved (i.e., toxicity has resolved to Grade ≤ 1 or is deemed irreversible)
- Current or anticipated need for drugs that are known cytochrome P450 isozyme CYP3A4 or CYP2C8 inducers or inhibitors; only exception is oral glucocorticoids, which are a required premedication for docetaxel
- Patient received previous treatment with oral AC480
- Patient using herbal and dietary supplements that may interact with CYP3A4
- Patient received radiation therapy or major surgery within one month of Cycle 1 Day 1
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- Patient has evidence of clinically unstable brain metastases (controlled and stable brain metastasis must be previously treated and asymptomatic)
- Patient has uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within 6 months prior to study entry;
- Uncontrolled angina within 6 months prior to study entry;
- History of congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4;
- LVEF that is ≤50% (or ≥ institutional lower limit of normal);
- Heart rate <50 beats per minute;
- Diagnosed or suspected congenital long QT syndrome;
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes [TdP]);
- Prolonged corrected interval between the Q wave and T wave (QTc) by Fridericia's correction factor (QTcF) interval on pre-entry ECG ≥450 ms (average of 3 ECG readings done in triplicate);
- Any history of second or third degree heart block;
- Uncontrolled hypertension;
- Obligate need for a cardiac pacemaker;
- Complete left bundle branch block;
- Atrial fibrillation; and
- Abnormal baseline Troponin-I.
- Patient is using drugs (or has medical conditions) that are generally accepted to have a risk of causing torsades de pointes (TdP) patients who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is greater) prior to the first dose of AC480IV
- Patient is in need of anticoagulation therapy except for low-dose heparin or low-dose coumadin for maintenance of patency of central venous access or prevention of deep vein thrombosis (DVT)
- Women who are pregnant or breastfeeding
- Male or female patients who are sexually active and unwilling to take contraceptive measures for the duration of the treatments and for 3 months following discontinuation of AC480IV
- Patient with serious uncontrolled concurrent medical illness including but not limited to ongoing or active infection, and "currently active" second malignancies other than non-melanoma skin cancers
- Patient with psychiatric illness or social situations that would limit compliance with treatment or adequate informed consent
- Patient has pre-existing peripheral neuropathy Grade >1
- Patient has prior hypersensitivity reaction or intolerance to docetaxel or other drugs formulated with polysorbate 80
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
University of California San Francisco (UCSF)
San Francisco, California, 94118
About this study
Official title: Open-label, Phase 1 Trial to Evaluate the Safety and Pharmacokinetic Parameters of a 2-day Pulse of Intravenous (IV) AC480 (AC480IV) Administered as Monotherapy and in Combination With Docetaxel in Patients With Advanced Solid Tumors
AC480IV will be administered as a monotherapy and then in combination with docetaxel in patients with locally advanced or metastatic solid tumors for whom there are no standard or curative therapies available. It is designed to evaluate the safety and pharmacokinetic parameters of AC480IV as monotherapy and also in combination with docetaxel under the conditions of the study.
Read the detailed description
A Phase I study to determine safety and tolerability of AC480IV with and without Docetaxel in subjects with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- AC480IV, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC480IVDrug
Also called AC480IV•Esylate
AC480IV will be administered as an infusion using a dose escalation design.
DocetaxelDrug
Also called Taxol
Docetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration.
| Study group | Role | What they receive |
|---|---|---|
| AC480IV | Experimental | Dose range finding study Receives: Drug: Docetaxel |
| Docetaxel | Experimental | Dose range finding study in subjects with solid tumors Receives: Drug: AC480IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability, including the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD), of a 2-day pulse of AC480IV both as monotherapy and in combination with docetaxel in patients with advanced solid tumor malignancies.
The primary outcome of the study will be safety and tolerability of the study treatment as measured by physical examinations, adverse events, clinical chemistry evaluations, ECG assessments and the report of dose-limiting toxicity as outlined in the protocol.
Measured: 18 months
Secondary outcomes (4)
Determine the pharmacokinetic (PK) parameters (Cl, Vd, Cmax, Clast, AUClast, AUCinf, t1/2, etc.) of AC480IV and docetaxel as monotherapy and in combination.
This study is designed to evaluate the safety and PK parameters of AC480IV as monotherapy and also in combination with docetaxel.
Measured: Measured at specified timepoints during 1st and/or 2nd cycles of treatment.
Determine any preliminary evidence of efficacy of AC480IV as monotherapy or in combination with docetaxel by assessing tumor response and time to disease progression.
Efficacy assessments will be completed within 7 days after the end of Cycle 3 and then every 3 cycles thereafter. Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be used to assess radiographic response.
Measured: 18 months
Evaluate HER profile and Ras mutation status in patients' tumors
If possible, patients with tumors known to express HER receptors, such as head and neck, lung adenocarcinoma, upper GI/esophageal, and breast cancers will be included.
Measured: Measured in specified dosing cohorts at various timepoints during 1st and/or 2nd cycles of treatment.
Evaluate whether AC480IV has anti-metabolic activity in the tumor microenvironment.
Tumor metabolism will be assessed by comparing pre-dose and postdose assessments.
Measured: Measured in specified dosing cohorts at various timepoints during Part 1 of this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionJun 2013
Why it stopped: Clinical investigations have been discontinued and transfer to BMS 3/24/2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Gammon, MB BS, MRCP, Study director, Interim Chief Medical Officer / Ambit Biosciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245543
- Sponsor's protocol ID
- AC480IV-001
- Status last verified
- Oct 2015
- First submitted
- 17 Nov 2010
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase 1 Trial to Evaluate the Safety and Pharmacokinetic Parameters of a 2-day Pulse of Intravenous (IV) AC480 (AC480IV) Administered as Monotherapy and in Combination With Docetaxel in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01245543
- Acronym / sponsor ID
- AC480IV-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical investigations have been discontinued and transfer to BMS 3/24/2015
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Nov 2010 (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.
AC480IV will be administered as a monotherapy and then in combination with docetaxel in patients with locally advanced or metastatic solid tumors for whom there are no standard or curative therapies available. It is designed to evaluate the safety and pharmacokinetic parameters of AC480IV as monotherapy and also in combination with docetaxel under the conditions of the study.
Detailed description
A Phase I study to determine safety and tolerability of AC480IV with and without Docetaxel in subjects with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC480IV | Experimental | Drug: DocetaxelDose range finding study |
| Docetaxel | Experimental | Drug: AC480IVDose range finding study in subjects with solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female age ≥18 years
- Provide written informed consent
- Has histological diagnosis of a primary solid tumor malignancy that meets study criteria
- Has measurable disease (or evaluable if not in MTD expansion cohort) via computed tomography (CT) or magnetic resonance imaging (MRI) scans with or without non-measurable tumors (a lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of that lesion prior to enrollment)
- Less than 4 prior systemic cancer therapies (with the exception of hormonal agents), including experimental agents, prior HER-family TKI therapies, and prior docetaxel and other taxane therapy; there are no limits to the number of prior therapies for Part 1
Key exclusion criteria (30 listed)
- Patient is currently receiving or has received within the last month prior to Cycle 1 Day 1 (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin) other chemotherapeutic, hormonal, or investigational anti-cancer agents with the exception of gonadal suppression agents and bisphosphonates for osteoporosis and skeletal metastases which may be continued while on study
- Patient has received other chemotherapeutic, hormonal, or investigational anti cancer agents that are outside of the timeframe described above and thus would be allowed in the study, but has toxicity that is unresolved (i.e., toxicity has resolved to Grade ≤ 1 or is deemed irreversible)
- Current or anticipated need for drugs that are known cytochrome P450 isozyme CYP3A4 or CYP2C8 inducers or inhibitors; only exception is oral glucocorticoids, which are a required premedication for docetaxel
- Patient received previous treatment with oral AC480
- Patient using herbal and dietary supplements that may interact with CYP3A4
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 |
|---|---|---|
| AC480IVAlso: AC480IV•EsylateAC480IV will be administered as an infusion using a dose escalation design. | Drug | Docetaxel |
| DocetaxelAlso: TaxolDocetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration. | Drug | AC480IV |
Primary outcome
Determine the safety and tolerability, including the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD), of a 2-day pulse of AC480IV both as monotherapy and in combination with docetaxel in patients with advanced solid tumor malignancies.
Time frame: 18 months
The primary outcome of the study will be safety and tolerability of the study treatment as measured by physical examinations, adverse events, clinical chemistry evaluations, ECG assessments and the report of dose-limiting toxicity as outlined in the protocol.
4 secondary outcomes
Determine the pharmacokinetic (PK) parameters (Cl, Vd, Cmax, Clast, AUClast, AUCinf, t1/2, etc.) of AC480IV and docetaxel as monotherapy and in combination.
Time frame: Measured at specified timepoints during 1st and/or 2nd cycles of treatment.
Determine any preliminary evidence of efficacy of AC480IV as monotherapy or in combination with docetaxel by assessing tumor response and time to disease progression.
Time frame: 18 months
Evaluate HER profile and Ras mutation status in patients' tumors
Time frame: Measured in specified dosing cohorts at various timepoints during 1st and/or 2nd cycles of treatment.
Evaluate whether AC480IV has anti-metabolic activity in the tumor microenvironment.
Time frame: Measured in specified dosing cohorts at various timepoints during Part 1 of this study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Guy Gammon, MB BS, MRCP study director
Interim Chief Medical Officer / Ambit Biosciences Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC480IV and Docetaxel in people with Solid Tumors, run by Daiichi Sankyo at 2 sites 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 10 inclusion and 30 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: withdrawn, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the safety and tolerability, including the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD), of a 2-day pulse of AC480IV both as monotherapy and in combination with docetaxel in patients with advanced solid tumor malignancies. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.