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Advanced Solid TumorPhase 1/2NCT02884479

An Open-Label Phase I/II Clinical Study of PT-112 in Combination With Docetaxel in Subjects With Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects With Non-Small Cell Lung Cancer (NSCLC) in a Phase II Dose Confirmation Study

A Phase 1/2 study testing PT-112 and Docetaxel in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by SciClone Pharmaceuticals International (Cayman) Development Limited at 4 sites in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell Lung Cancer. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
PT-112 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
4 sitesTaiwan
Study dates
Aug 2016to Mar 2019
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

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • Male or female ≥ 20 years of age on the day of signing informed consent.
  • Subjects with advanced tumor of any histological type and meet the following eligibility criteria for the corresponding part of the study:
  • In Part 1, the subjects who failed at least one prior therapy must have pathologically confirmed advanced solid tumor of any histological type with preference of subjects with advanced NSCLC and either no available, or intolerable to, standard of-care treatment.
  • In Part 2, the subjects must have pathologically confirmed advanced NSCLC. Subjects are required to have evidence of measurable disease per RECIST v1.1.
  • Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
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  • Subject must have adequate organ function as indicated by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin ≥ 90 g/L or 5.6 mmol/L.
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated or directly measured creatinine clearance ≥ 60% lower limit of normal (LLN).
  • Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits).
  • Aspartate aminotransferase (AST [SGOT]) and/or alanine aminotransferase (ALT [SGPT]) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases.
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
  • Albumin ≥ 3 mg/dL.
  • Female subjects are eligible to enter and participate in the study if they are of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who
  • has had a hysterectomy
  • has had a bilateral oophorectomy (ovariectomy)
  • has had a bilateral tubal ligation
  • is post-menopausal (total cessation of menses for ≥ 1 year)
  • Childbearing potential, have a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), are not breast feeding, and use adequate contraception before study entry and throughout the study until 180 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
  • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • Any intra-uterine device with a documented failure rate of less than 1% per year.
  • Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; or diaphragm with spermicide; or male condom and diaphragm.
  • Male subjects are eligible to enter and participate in the study if they are vasectomized or agree to use of contraception during the study treatment period and for at least 180 days after the last dose of the study drug.
  • Willing and able to provide written informed consent and comply with the requirements of the study.

Who cannot join

  • Subjects meeting any of the following criteria are ineligible for participation in the study:
  • Any cytotoxic chemotherapy within 21 days, prior to initiation of study drug.
  • Receipt of more than three prior regimens of cytotoxic chemotherapy (immunotherapy and targeted therapy will not be counted as a line of therapy).
  • History of hypersensitivity reaction to docetaxel and polysorbate 80 or any of its components.
  • Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
  • Evidence of peripheral neuropathy of Grade 2 or greater within 28 days prior to initiation of dosing.
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  • Symptomatic brain metastasis requiring active treatment.
  • Bone marrow reserve which, in the clinical judgment of the Principal Investigator, is not adequate for participation in this study.
  • Known allergy or hypersensitivity to Pt-containing agents, or known intolerance to a prior Pt-containing agent which, in the judgment of the Principal Investigator, precludes re-exposure to a Pt-containing agent.
  • Radiotherapy within 28 days prior to baseline and/or receipt of radiotherapy to >25 % of bone marrow volume.
  • Major surgery within 28 days prior to initiation of study drug combination.
  • Life expectancy <12 weeks.
  • Active or clinically unstable bacterial, viral, or fungal infection requiring systemic therapy.
  • Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
  • Clinically significant hearing impairment, as judged by the Principal Investigator.
  • Any of the following within 3 months prior to initiation of study drug: uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4, APPENDIX 2), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism.
  • Unstable cardiac dysrhythmias or persistent prolongation of the QTc (Fridericia) interval to >450 msec for males or >470 msec for females.
  • In Part 2, any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was successfully treated with curative intent more than two years prior to study entry.
  • Use of any investigational agents within 28 days prior to the screening.
  • Pregnant or lactating female.

Trial locations and contacts

4 sites in 1 country.

Crystal Qin, M.D, Ph.D contact

86-21-2319 3802

cqin@sciclone.com

Taiwan4 sites, 4 recruiting

  • Changhua Christian Hospital

    Changhua County

    Chien-Te Li

    Chien-Te Li

    Recruiting

  • China Medical University & Hospital

    Taichung

    Te-Chun Hsia

    Te-Chun Hsia

    Not yet recruiting

  • National Cheng Kung University Hospital

    Tainan

    Wu-Chou Su

    Wu-Chou Su

    Recruiting

  • Tri-Service General Hospital

    Taipei

    Ching-Lian Ho

    Ching-Lian Ho

    Recruiting

Other trials in Taiwan

About this study

The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell Lung Cancer.

Being tested
PT-112, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PT-112Drug

    Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

  • DocetaxelDrug

    Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

Study groups in NCT02884479
Study groupRoleWhat they receive
PT-112 + DocetaxelExperimentalIncreasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.
Receives: Drug: PT-112; Drug: Docetaxel

What is being measured

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

  1. dose-limiting toxicities (DLTs)

    Measured: Day 0 to Day 28

  2. area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast)

    Measured: Cycle 1, Day 1: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 5, 8, 12, 24 hours post dose Cycle 1, Day 8: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24 hours post dose Cycle 2, Day 8: Pre-dose, 1, 2, 4 hours post dose Cycle 3 & 4, Day 8: Pre-dose

Secondary outcomes (1)

  1. Adverse Events

    Measured: Cycle 1: Day 1, Day 8, Day 15; Cycle 2: Day 1, Day 8; Follow up: 30 days post final dose

Timeline

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

  1. First posted31 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionMar 2019 (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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02884479
Sponsor's protocol ID
SCI-PT112-ONC-P1-001
Status last verified
Mar 2018
First submitted
17 Aug 2016
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PT-112 and Docetaxel in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by SciClone Pharmaceuticals International (Cayman) Development Limited at 4 sites in Taiwan.

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 28 inclusion and 20 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 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan. 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 Crystal Qin, M.D, Ph.D (86-21-2319 3802, cqin@sciclone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dose-limiting toxicities (DLTs) (time frame: Day 0 to Day 28). 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 NCT02884479.

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 25 Apr 2018.

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