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NSCLC Stage IIIBPhase 1SPH1188-11NCT03231475

Phase I Study of SPH1188-11 in NSCLC

A Phase 1 study testing SPH1188-11 in people with NSCLC Stage IIIB and NSCLC Stage IV, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
NSCLC Stage IIIB, NSCLC Stage IV
What is being tested?
SPH1188-11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
21 Jul 2017to 31 Mar 2022
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70years old, male or female.
  • Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC),Stage IIIBorIV, previous treatment with 1st EGFR-TKI, and/or previous chemotherapy. Regardless of EGFR mutation status.
  • At least one measurable disease according to RECIST 1.1.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
  • Females should be using adequate contraceptive measures from the time of screening until 3 months after discontinuing study treatment, should not be breast feeding and must have a negative pregnancy test 7days prior to start of dosing. Males should be willing to use barrier contraception during the trial and 3 months after discontinuing study treatment.
  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

Who cannot join

  • Treatment with an EGFR-TKI(eg, erlotinib, gefitinib, icotinib) within 7 days or approximately 5x half-life of study entry.
  • Previous treatment with 2nd EGFR-TKI or 3rd EGFR-TKI(eg, afatinib, osimertinib).
  • Any cytotoxic chemotherapy or anticancer drugs within 4 weeks of the first dose of study treatment.
  • Major surgery(excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
  • Radiotherapy within 4 weeks of the first dose of study treatment.
  • Patients currently receiving(or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors of CYP3A4/CYP2D6, and/or potent inducers of CYP3A4/CYP2D6.
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  • Laboratory values within 7 days of the first dose of study treatment:
  • Absolute neutrophil count<1.5×10^9/L
  • Platelet count <100×10^9/L
  • Haemoglobin<90 g/L
  • Alanine aminotransferase>2.5 times the upper limit of normal(ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases.
  • Aspartate aminotransferase>2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases.
  • Total bilirubin>1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert's Syndrome(unconjugated hyperbilirubinaemia) or liver metastases.
  • Creatinine>1.5 times ULN concurrent with creatinine clearance <50ml/min(measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is>1.5 times ULN.
  • Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events(CTCAE) grade 1 at the time of starting study treatment (except alopecia and prior platinum-therapy related neuropathy)
  • Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
  • Any evidence of severe or uncontrolled systemic diseases, including active bleeding, active infection including hepatitis B(HBsAg+ and HBV-DNA+), hepatitis C and human immunodeficiency virus(HIV).
  • Cardiac criteria: QTc>480msec. LVEF<50%. Any clinically important abnormalities in rhythm, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family in first degree relatives or any concomitant medication known to prolong the QT interval.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Idiopathic pulmonary fibrosis.
  • Chronic gastrointestinal diseases, characterized by diarrhea.
  • Inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of SPH1188-11.
  • History of Keratitis, ulcerative keratitis, severe xerophthalmia.
  • Previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured.
  • History of neurological or mental disorders, including epilepsy or dementia.
  • Allergy to the test drug or any excipient of the product.
  • Participate in other drug clinical trials within 4 weeks of the first dose of study treatment.
  • Receiving any other anti-tumor therapy.
  • Women who are breast feeding or pregnant.
  • Judgment by the investigator that the patient should not participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase I, Open-label Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of SPH1188-11 Tablets for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Read the detailed description

Phase I dose escalation study

Being tested
SPH1188-11
Keywords
NSCLC, EGFR-TKI
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.

  • SPH1188-11Drug

    Also called SPH1188

    qd.po

Study groups in NCT03231475
Study groupRoleWhat they receive
SPH1188-11ExperimentalSPH1188-11 dose escalation, 50mg/100mg/200mg/300mg/450mg/600mg
Receives: Drug: SPH1188-11

What is being measured

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

  1. DLT and MTD of SPH1188-11

    Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH1188-11, to find DLT and MTD

    Measured: 28 days

Secondary outcomes (7)

  1. Tmax of SPH1188-11

    Evaluate the Tmax of SPH1188-11

    Measured: 28 days

  2. ORR of SPH1188-11

    Objective response rate(ORR) according to RECIST 1.1, ORR=CR+PR

    Measured: 52 weeks

  3. PFS of SPH1188-11

    Progress free survival(PFS)

    Measured: 52 weeks

  4. DCR of SPH1188-11

    Disease control rate(DCR), DCR=CR+PR+SD

    Measured: 52 weeks

  5. Cmax of SPH1188-11

    Evaluate the Cmax of SPH1188-11

    Measured: 28 days

  6. AUC of SPH1188-11

    Evaluate the AUC of SPH1188-11

    Measured: 28 days

  7. T1/2 of SPH1188-11

    Evaluate the T1/2 of SPH1188-11

    Measured: 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 posted27 Jul 2017
  2. Study start21 Jul 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Mar 2022 (estimated)

Why it stopped: Board decision

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03231475
Sponsor's protocol ID
SPH1188-11-101
Acronym
SPH1188-11
Status last verified
Oct 2021
First submitted
6 Jun 2017
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPH1188-11 in people with NSCLC Stage IIIB and NSCLC Stage IV, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.

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 7 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 8 Nov 2021. 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 China. 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?

DLT and MTD of SPH1188-11 (time frame: 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 NCT03231475.

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 8 Nov 2021.

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