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NPCPhase 2NCT03158324

Phase IIa Dose-Expansion and Biomarker Study of OPB-111077

A Phase 2 study testing OPB-111077 in people with NPC and Refractory Tumor, run by National University Hospital, Singapore at 1 site in Singapore.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
NPC, Refractory Tumor
What is being tested?
OPB-111077
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSingapore
Study dates
22 May 2017to 30 Nov 2020
Phase
Phase 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 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, locally recurrent or metastatic solid tumors, who have failed standard treatment
  • Subjects with NPC will be eligible as long as they have received prior platinum therapy
  • Subjects with other types of solid tumors will be eligible if: i) their archival tumor sample shows over-expression oxidative phosphorylation markers e.g., PGC-1α/ SIRT1 or ii) they have oncogene-addicted cancers (e.g., EGFR mutation-positive NSCLC, EML4-ALK fusion NSCLC, BRAF-mutant melanomas, GIST, RET-driven thyroid cancers) which have become resistant to primary TKI therapy
  • All subjects must have at least one tumour lesion (primary or metastatic) that is suitable for free-hand or image-guided biopsy at baseline.
  • Age ≥ 21 years, Eastern Cooperative Oncology Group (ECOG) performance status < 1
  • Adequate bone marrow, liver and renal function
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  • Baseline serum lactate ¬<3mmol/l
  • Capable of swallowing tablets
  • Recovery from any previous drug- or procedure-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 0 or 1 (except alopecia), or to baseline preceding the prior treatment.
  • Signed informed consent obtained before any study specific procedure. Subjects must be able to understand and be willing to sign the written informed consent.

Who cannot join

  • Chemotherapy, radiotherapy, surgery, immunotherapy or other therapy within 3 weeks of starting investigational medicinal product (IMP).
  • Use of any prohibited medications (CYP3A4 inhibitors and inducers) or medications which may predispose to lactic acidosis (e.g., metformin, nucleoside analogue reverse within 1 week prior to start of study drug administration
  • Pregnancy or breastfeeding.
  • Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study medication, and a negative result must be documented before start of study medication. Women of childbearing potential and men, must agree to use adequate contraception (barrier method of birth control) upon signing the informed consent form until at least 3 months after the last study drug administration.
  • Known or suspected allergy to the investigational agent or any agent given in association with this study.
  • Concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis \& T1) or any cancer curatively treated less than 3 years prior to study entry.
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  • Interstitial lung disease with ongoing signs and symptoms at the time of screening.
  • Patients with CTCAE Grade 2 or higher peripheral neuropathy.
  • History of significant cardiac disease: congestive cardiac failure > NYHA class II, ongoing unstable angina, new-onset angina or myocardial infarction within the past 3 months

Trial locations and contacts

1 site in 1 country.

Andrea Wong, MBBS contact

(65) 6779 5555

andrea_la_wong@nuhs.edu.sg

Boon Cher Goh, MBBS contact

(65) 6779 5555

phcgbc@nuhs.edu.sg

Singapore1 site, 1 recruiting

  • National University Hospital, Singapore

    Singapore, 119228

    Andrea Wong, MBBS, +65 6772 4621, Andrea_LA_Wong@nuhs.edu.sg

    Boon Cher Goh, MBBS

    Recruiting

Other trials in Singapore

About this study

Official title: Phase IIa Dose-Expansion and Biomarker Study of OPB-111077 in An Enriched Population of Treatment-Refractory Advanced Solid Tumors

This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry.

Read the detailed description

This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry. Patients on the proposed study will be treated with the RPII dose of OPB-111077 (600mg on a 4 days-on, 3 days-off per week schedule). They will be enrolled in two parallel cohorts: i. patients with tumors predicted to be dependent on oxidative phosphorylation metabolism or oncogene addicted tumors which have developed resistance to primary TKI therapy, or ii. patients with nasopharyngeal carcinoma

Each cohort will contain 11-26 patients, over a period of 12-36 months. Subjects will receive OPB-111077 in 28-day cycles till disease progression or intolerable toxicity. Mandatory tumour biopsies will be performed at baseline and on cycle 1 day 15 (where feasible and accessible). Circulating biomarker blood sampling will be performed on days 1, 11 and 15 of cycle 1, and upon completion of OPB-111077 dosing. Pharmacokinetics blood sampling will be performed on days 11 and 15 of cycle 1. Safety assessments will be performed on cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, bi-weekly till week 8, then monthly thereafter and response assessments will be performed every 8 weeks. Metabolic response assessment by PET/CT will be performed after 2 cycles of treatment, while radiologic response assessment will be performed after every 2 cycles of OPB-111077 from cycle 4 onwards.

Being tested
OPB-111077
Medical subject headings
Neoplasms

What participants receive

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

  • OPB-111077Drug

    Receive 600 mg of OPB-111077 on a 4 days-on, 3 days-off per week in 28-day cycles till disease progression or intolerable toxicity

Study groups in NCT03158324
Study groupRoleWhat they receive
Advanced refractory solid tumorsExperimentalPatients with advanced refractory solid tumors will be enrolled.
Receives: Drug: OPB-111077

What is being measured

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

  1. Objective response rates

    This will be calculated as the percentage of evaluable patients achieving complete and partial response with OPB-111077 treatment, according to the RECIST 1.1 criteria

    Measured: 3 years

Secondary outcomes (3)

  1. Metabolic response rates

    This will be calculated as the percentage of evaluable patients achieving complete and partial metabolic response on 18F]-FDG PET/CT after 2 cycles of OPB-111077, as determined by the EORTC PET response criteria.

    Measured: 3 years

  2. Progression free survival

    This is defined as the time from the start of study treatment to documented progression of disease or death.

    Measured: 3 years

  3. Haematologic and non-haematologic toxicities (all grades)

    To evaluate the haematologic and non-haematologic toxicities of OPB-111077

    Measured: 3 years

Timeline

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

  1. First posted18 May 2017
  2. Study start22 May 2017
  3. Primary completion22 May 2020 (estimated)
  4. Study completion30 Nov 2020 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Two parallel cohorts will be implemented: i. patients with tumors predicted to be dependent on oxidative phosphorylation metabolism or oncogene addicted tumors which have developed resistance to primary TKI therapy, or ii. patients with nasopharyngeal carcinoma
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03158324
Sponsor's protocol ID
2016/01181
Other IDs
2016
Status last verified
Apr 2017
First submitted
16 May 2017
Last updated
15 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alam MM, Lal S, FitzGerald KE, Zhang L. A holistic view of cancer bioenergetics: mitochondrial function and respiration play fundamental roles in the development and progression of diverse tumors. Clin Transl Med. 2016 Mar;5(1):3. doi: 10.1186/s40169-016-0082-9. Epub 2016 Jan 26.

    PubMed 26812134

  • Vellinga TT, Borovski T, de Boer VC, Fatrai S, van Schelven S, Trumpi K, Verheem A, Snoeren N, Emmink BL, Koster J, Rinkes IH, Kranenburg O. SIRT1/PGC1alpha-Dependent Increase in Oxidative Phosphorylation Supports Chemotherapy Resistance of Colon Cancer. Clin Cancer Res. 2015 Jun 15;21(12):2870-9. doi: 10.1158/1078-0432.CCR-14-2290. Epub 2015 Mar 16.

    PubMed 25779952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPB-111077 in people with NPC and Refractory Tumor, run by National University Hospital, Singapore at 1 site in Singapore.

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 9 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 15 Jun 2017. 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 Singapore. 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 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 Andrea Wong, MBBS ((65) 6779 5555, andrea_la_wong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rates (time frame: 3 years). 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 NCT03158324, which also lists 2 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 15 Jun 2017.

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