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High Grade Fallopian Tube Serous AdenocarcinomaPhase 1/2NCT02756130

Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (HGSOC)

A Phase 1/2 study testing Birinapant, Carboplatin and Laboratory Biomarker Analysis in people with High Grade Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I/II trial studies how well birinapant and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as birinapant and carboplatin work in different ways to stop the growth of tumor cells, either by killing the… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Birinapant, Carboplatin and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Aug 2018to 1 Feb 2021
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have measurable disease by imaging defined as tumor that can be measured >= 10 mm with multiparametric magnetic resonance imaging (MRI) (primary modality of imaging) or computed tomography (CT) (as an alternative) or >= 10 mm by caliper on physical examination
  • Participant is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to initiation of any screening or study-specific procedures
  • The participant must have a histologic diagnosis of recurrent high grade serous ovarian cancer (ovarian, tubal, peritoneal), to be treated with chemotherapy
  • Participants must have an image guided biopsy performed to yield fresh tissue for the in vitro organoid bio-assay and two biomarker testing (western blot and immunohistochemistry)
  • Only patients with tumors that score positive in the in vitro organoid bio-assay will be enrolled in the clinical trial; patients with tumors that score negative in this bio-assay will be considered screening failures and will not be enrolled in the clinical trial
  • Participant must have either no neuropathy (sensory and motor) or neuropathy less than or equal to grade 1
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  • The participant must have an Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 at screening
  • The participant must have a life expectancy of greater than 12 weeks
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000/ mm^3
  • Hemoglobin >= 9 g/dL or equivalent
  • Total bilirubin =< 1.5 ? institutional upper limit of normal (ULN), unless known Gilbert?s syndrome has been diagnosed
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 ? institutional ULN (=< 5 ? ULN if liver metastasis)
  • Serum creatinine =< 1.5 ? ULN or creatinine clearance >= 50 mL/min/1.73 m^2
  • Amylase < ULN
  • Lipase < ULN
  • Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative (serum or urine) pregnancy test within 72 hours before the first study-drug dose; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the participant to be eligible
  • Female participants of childbearing potential should ensure use of a highly effective method of birth control as defined by the investigator, for example, those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner during the study and for a period of at least 4 months following the last dose of any drug administered during the study

Who cannot join

  • Patients with tumors that score negative in the in vitro organoid bio-assay will be excluded
  • Patients with non-measurable disease < 10 mm on multiparametric MRI or CT scan will be excluded
  • Participants with a secondary malignancy that is progressing or requires active treatment; participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative treatment are not excluded
  • Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to birinapant or its constituents
  • Participants requiring the use of anti-tumor necrosis factor (anti-TNF) therapies, such as infliximab, or has received treatment with anti-TNF therapies within 5 half-lives of the drug
  • Participants with an uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, autoimmune disease or inflammatory diseases, or psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant women or women who expect to conceive a child are excluded from the study; breastfeeding should be discontinued if the mother is treated on this study
  • Participants who have a known active infection requiring systemic therapy, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
  • Participants with a history of cranial nerve palsy
  • Participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is an investigational site or sponsor-investigator staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is granted allowing exception to this criterion for a specific subject
  • In the opinion of the investigator, the participant is an unsuitable candidate for this study
  • Patients who are taking or anticipate taking any maintenance therapy while actively being treated on protocol or while being followed on protocol will be excluded; an example of this would be maintenance therapy with a Poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor such as olaparib

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase I/II, Single Center, Proof-of-Concept Study of Birinapant in Combination With Platinum Based Chemotherapy Targeting Recurrent High Grade Serous Ovarian Carcinomas (HGSOC)

This phase I/II trial studies how well birinapant and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as birinapant and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess whether addition of birinapant to carboplatin therapy can reduce the percentage of platinum resistant tumor initiating cells by 50% compared to pre-therapy biopsies in participants with recurrent high grade serous ovarian carcinomas (HGSOC) whose tumors score positive in the in vitro organoid bioassay test.

II. Assess target engagement by comparing levels of cellular inhibitor of apoptosis protein (cIAP) and percentage of apoptotic cells in pre-versus post therapy tumor biopsies (obtained after three cycles of treatment).

SECONDARY OBJECTIVES:

  1. To see if there is an increase in progression free survival of participants treated with co-therapy (birinapant/carboplatin) compared with historic controls.

TERTIARY OBJECTIVES:

  1. Develop a companion diagnostic test by correlating clinical response seen in participants with two biomarker assays developed in our laboratory.
  2. Measuring levels of cIAP protein by western blot in tumor biopsies obtained from participants prior to start of therapy.
  3. Measuring percentage of cIAP positive cells by immunohistochemistry in tumor biopsies obtained from participants prior to start of therapy.

OUTLINE:

Patients receive birinapant intravenously (IV) over 30 minutes on days 1 and 8, and carboplatin IV over 30 minutes to 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years from Course 1, Day 1.

Being tested
Birinapant, Carboplatin, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • BirinapantDrug

    Also called TL32711

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT02756130
Study groupRoleWhat they receive
Treatment (birinapant, carboplatin)ExperimentalPatients receive birinapant IV over 30 minutes on days 1 and 8, and carboplatin IV over 30 minutes to 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Birinapant; Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

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

  1. Change in percentage of cancer initiating cells

    Will be measured using a 3-dimensional organoid assay; population analysis using flow cytometry to measure the overall percentage of platinum resistant tumor initiating cells and by immunohistochemistry. Percent cellular inhibitor of apoptosis (cIAP) positive and amount of cIAP protein will be computed using either the non parametric Wilcoxon signed rank test or the paired t test if the data follow a normal distribution. Full summary statistics including the mean and median difference and the corresponding 95% confidence bounds will be reported. We will report scatter plots and the non parametric Spearman correlation coefficients among these four measures of platinum resistant tumor initiating cells pre-therapy as well as the post- minus pre-treatment difference.

    Measured: Baseline up to 2 years

  2. Pharmacodynamic analysis of cellular inhibitor of apoptosis (cIAP) protein

    Will measure the level of cIAP protein in pre- versus (vs). post-therapy tumors, measured by quantitative western blot, compared to a purified cIAP standard of known amount loaded on the same gel. Percent cIAP positive and amount of cIAP protein will be computed using either the non parametric Wilcoxon signed rank test or the paired t test if the data follow a normal distribution. Full summary statistics including the mean and median difference and the corresponding 95% confidence bounds will be reported. We will report scatter plots and the non parametric Spearman correlation coefficients among these four measures of platinum resistant tumor initiating cells pre-therapy as well as the post- minus pre-treatment difference.

    Measured: Baseline up to 2 years

Secondary outcomes (1)

  1. Progression free survival (PFS) assessed using imaging (multiparametric magnetic resonance imaging [MRI] (primary modality of imaging) of computed tomography (CT) and the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

    The secondary analysis in each group will be comparison of PFS to known historical PFS. The PFS curve will be estimated using the Kaplan-Meier method and the sample PFS curve will be compared to the known historical population curve using the one sample log rank test.

    Measured: Start of therapy and progression of disease or death whichever comes first, assessed up to 2 years

Timeline

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

  1. First posted29 Apr 2016 (estimated)
  2. Study start1 Aug 2018 (estimated)
  3. Primary completion1 Feb 2020 (estimated)
  4. Study completion1 Feb 2021 (estimated)

Why it stopped: funding was not secured

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02756130
Sponsor's protocol ID
16-000746
Other IDs
NCI-2016-00596, GODL001, 16-000746
Status last verified
Aug 2018
First submitted
22 Apr 2016
Last updated
13 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Birinapant, Carboplatin and Laboratory Biomarker Analysis in people with High Grade Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site 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 18 inclusion and 12 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 13 May 2025. 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 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 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?

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?

Change in percentage of cancer initiating cells (time frame: Baseline up to 2 years). 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 NCT02756130.

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 13 May 2025.

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