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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1/2NCT01764087

A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors

A Phase 1/2 study testing KX2-391 and Paclitaxel in people with Unspecified Adult Solid Tumor, Protocol Specific and Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer, respectively in Phase II. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
KX2-391 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSouth Korea
Study dates
Dec 2012to May 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Phase I Portion:
  • Diagnosis of solid tumors on histopathological examination or cytological examination for which no standard of care is available or conventional treatment modalities have no therapeutic effect at the time of entering into the study
  • Phase II Portion:
  • Diagnosis of advanced/metastatic/recurrent stomach cancer or breast cancer on histopathological examination or cytological examination for which no standard of care is available or conventional treatment modalities have no therapeutic effect at the time of entering into the study
  • Subjects with stomach cancer without prior taxane therapy
  • Subjects with breast cancer with prior taxane therapy
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  • (Optional) Providing exploratory biomarker informed consent form to obtain archival tumor tissue and/or new tumor biopsy sample
  • Common:
  • Based on clinical screening,
  • ① If radiotherapy was given, at least 4 weeks should have passed from the last treatment date and the patient should have recovered from the toxicity (However, for limited regional radiotherapy, at least 2 weeks from the last treatment date)
  • ② If hormonal therapy was given, at least 2 weeks should have passed from the last treatment date and the patient should have recovered from the toxicity.
  • ③ If chemotherapy was given, at least 3 weeks should have passed from the last treatment date and the patient should have recovered from the toxicity (However, for nitrosourea or mitomycin, at least 6 weeks)
  • Aged ≥ 20 years
  • ECOG (Eastern Cooperative Oncology Group) ≤ 2
  • Life expectancy ≥ 12 weeks
  • Should meet the followings,
  • ① Bone marrow function ANC (Absolute Neutrophil Count) ≥ 1.5 X 109/L, PLT (Platelet Count) ≥ 100 X 109/L, Hemoglobin ≥ 9.0 g/dl (In the case of hemoglobin of < 9.0 g/dl, the patient can be enrolled if the value is reversed to ≥ 9.0 g/dl.)
  • ② Kidney function Creatinine Clearance > 50 ml/min or Serum Clearance ≤ 1.5 mg/dl
  • ③ Liver function AST (Aspartate Aminotransferase)/ALT (Alanine Aminotransferase)/ALP (Alkaline Phosphatase) ≤ 3.0 X UNL and Total bilirubin ≤ 2.0 mg/dl (With bone metastasis, ALP ≤ 5.0 X UNL)
  • At least one measurable lesions with the length of the longest diameter of ≥ 10 mm on spiral CT or multidetector CT or ≥ 20 mm on conventional CT
  • Subjects who voluntarily consent to participate in this study and sign the written informed consent form

Who cannot join

  • Uncontrolled central nervous system metastasis
  • Malignant ascites requiring surgical treatment
  • Subjects who have blood malignancies including leukemia; or who have received or will receive bone marrow transplantation
  • Severe concurrent diseases as follows,
  • ① History of unstable angina, heart failure, atrial or ventricular arrhythmia requiring pharmacological treatment, or having received treatment for myocardial infarction within 6 months (however, may be included under the judgment of the investigator if medically controlled), heart failure of Class III or IV by New York Heart Association Classes, or left ventricular ejection fraction of < 40%
  • ② Receiving therapeutic dose administration of coumarin-type anticoagulants (however, up to 2 mg daily is permitted for line opening)
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  • ③ Uncontrolled diabetes (fasting plasma glucose > 2.0 X UNL), severe hypertension, thyroid disorder and active infectious disease
  • ④ Psychiatric or neurological history including dementia or epilepsy which may threaten the compliance with this protocol
  • ⑤ A condition not allowing oral application of tablet formulation, and any clinically significant gastrointestinal abnormalities which may interfere with taking, passing or absorption of the study drug
  • Using disallowed concomitant medications (strong CYP3A4 (Cytochrome P450 3A4) inhibitors or inducers) (When a patient is using any of the disallowed concomitant medications below, wash-out of 1 week from the medication date is required)
  • Received other investigational product within 4 weeks prior to the administration of this study drug
  • Pregnant or breast-feeding women (however, women with 12 months of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (alone or with hysterectomy) at least 6 weeks ago, with appropriate clinical profile (e.g., appropriate age, history of vasomotor symptoms), will be considered women postmenopausal and of non-childbearing potential. In the case of oophorectomy alone, a woman will be considered to be of non-childbearing potential only if her reproductive condition is confirmed by follow-up hormone level assessment)
  • History of hypersensitivity to paclitaxel, compounds with similar chemical structure, or cremophor (polyoxyethylated castor oil) ingredient
  • Neuropathy of grade ≥ 3 based on clinical screening
  • Known history of hepatitis B or C and known history of HIV serum positive
  • Others unable to participate in the study under the judgment of the investigator

Trial locations and contacts

2 sites in 1 country.

Seock-Ah Im, M.D., Ph.D. contact

+82-2-2072-0850

Jee Hyun Kim, M.D., Ph.D. contact

+82-31-713-5132

South Korea2 sites, 2 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

    Yun Jin Kim, +82-31-787-1421

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul, 110-744

    Eunkyung Kim, +82-2-2072-7616

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label Phase I/II Study of KX2-391 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer, respectively in Phase II.

Being tested
KX2-391 and Paclitaxel
Keywords
Stomach Neoplasms, Breast Neoplasms, Carcinoma, Neoplasms, Paclitaxel, Tubulin Modulators, Antimitotic Agents, Protein Kinase Inhibitors, Enzyme Inhibitors, Pharmacologic Actions
Medical subject headings
Stomach Neoplasms, Breast Neoplasms, Carcinoma, Neoplasms

What participants receive

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

  • KX2-391 and PaclitaxelDrug

    Also called KX01, Taxol

    A treatment cycle in phase I will consist of 28 days, according to the following schedule:

    KX2-391 20 mg PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.

    The trial will initially test the combination of weekly paclitaxel and KX2-391 given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort, this intervention will be terminated

    A treatment cycle in phase II will consist of 28 days, according to the following schedule:

    KX2-391 MTD PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.

Study groups in NCT01764087
Study groupRoleWhat they receive
KX2-391 and PaclitaxelExperimentalThe phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. 3 or 6 subjects with solid tumor per dose group will likely be necessary to determine the MTD of KX2-391 in combination with weekly paclitaxel. With paclitaxel dose fixed at 80 mg/m2/weekly, KX2-391 treatment will be started at 20 mg dose once daily (QD) The phase II portion of this trial has a design to determine the efficacy of KX2-391 when administered in combination with paclitaxel in 20 subjects with stomach cancer and 20 subjects with breast cancer
Receives: Drug: KX2-391 and Paclitaxel

What is being measured

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

  1. Dose-limiting Toxicities (DLTs) in Phase I Portion

    Maximum tolerated dose (MTD) of KX2-391 in combination with weekly paclitaxel as determined by number of participants With DLTs related to KX2-391 in combination with weekly paclitaxel

    Measured: From start of the treatment to end of cycle 1, which are 4 weeks

  2. Tumor Overall Response Rates (ORRs) in Phase II Portion

    The efficacy (overall response rate; ORR; complete response (CR) + partial response (PR)) of KX2-391 in combination with weekly paclitaxel at the MTD established during the phase I portion of this trial based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1

    Measured: In every 2 cycles up to end of the treatment, an expected average of 16 weeks

Secondary outcomes (5)

  1. Pharmacokinetic (PK) Evaluation in Phase I Portion

    PK parameters, including but not limited to, plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2 of KX2-391 alone and in combination with weekly paclitaxel

    Measured: Time points at day 0, 1 and 8 in cycle 1

  2. The Preliminary Efficacy Data in Phase I Portion

    The preliminary efficacy of KX2-391 in combination with weekly paclitaxel as determined by ORRs based on RECIST 1.1

    Measured: In every 2 cycles up to end of the treatment, an expected average of 8 weeks

  3. Safety in Phase II Portion

    Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECG change monitoring as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03

    Measured: From start of the treatment to end of the treatment, an expected average of 16 weeks

  4. The Efficacy Data in Phase II Portion

    Overall survival (OS), progression free survival (PFS), time to tumor progression (TTP) and duration of response

    Measured: Up to die, an expected average of 24 weeks

  5. Pharmacokinetic (PK) Evaluation in Phase II Portion

    PK parameters, including but not limited to, plasma concentration, AUC0-t, Cmax, Tmax, and T1/2 of KX2-391 alone and in combination with weekly paclitaxel

    Measured: Time points at day 1 and 8 in cycle 1

Timeline

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

  1. First posted9 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2015 (estimated)
  4. Study completionMay 2016 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764087
Sponsor's protocol ID
HM-KXI-101
Status last verified
Mar 2014
First submitted
2 Jan 2013
Last updated
18 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KX2-391 and Paclitaxel in people with Unspecified Adult Solid Tumor, Protocol Specific and Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 2 sites in South Korea.

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 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Seock-Ah Im, M.D., Ph.D. (+82-2-2072-0850), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicities (DLTs) in Phase I Portion (time frame: From start of the treatment to end of cycle 1, which are 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764087.

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 18 May 2015.

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