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Neoplasms, Germ Cell and EmbryonalPhase 2NCT02533765

Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor

A Phase 2 study testing Olaparib in people with Neoplasms, Germ Cell and Embryonal, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is open-label, single-arm, two-stage phase II trial of olaparib in patients with relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the preliminary activity of Olaparib in GCT tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Germ Cell and Embryonal
What is being tested?
Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesItaly
Study dates
11 Sep 2015to 13 Feb 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥ 18 years old
  • Histologically verified metastatic gonadal GCT or extragonadal GCT originating from retroperitoneum or mediastinum.
  • Disease progression during cisplatin-based chemotherapy or disease progression or relapse after high-dose chemotherapy or disease progression or relapse after at least 2 different cisplatin-based regimens
  • patients who progressed during cisplatin-based therapy and who are not eligible for high-dose chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
  • Life expectancy ≥3 months
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  • At baseline adequate function of liver, kidneys and bone marrow
  • Neutrophils ≥ 1500 /mm3;
  • Hemoglobin ≥ 9.0 g/dL;
  • Platelets ≥ 80 x109/L;
  • Creatinine ≤ 1.5x upper limit of normal (ULN) In case of liver metastases increased levels of the following three parameters is acceptable:
  • Bilirubin ≤ 1.5 x ULN
  • serum glutamate oxaloacetate transaminase (SGOT (AST) ≤2.5 x ULN
  • serum glutamate pyruvate transaminase (SGPT (ALT) < 2.5 x ULN;
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice (ICH GCP), and national/local regulations.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • At least one measurable lesion that can be accurately assessed by CT/MRI/plain x-ray) at baseline and follow up visits.

Who cannot join

  • Systemic antitumor treatment within 21 days before study entry
  • Simultaneous radiotherapy to the only target lesion
  • Patients with resting ECG with QTc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome. If ECG demonstrates QTc >470 msec, patient will be eligible only if repeat ECG demonstrates QTc ≤470 msec
  • Patients who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures.
  • Patients with uncontrolled brain metastases.
  • Patients receiving prohibited classes of inhibitors of CYP3A4 (see section 6.5.1).
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  • Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Patients with any acute toxicities due to previous cancer treatment that have not resolved to a Common Toxicity Criteria for Adverse Effects (NCI-CTCAE v 4.03) grade 0 or 1 with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy.
  • Patients affected by myelodysplastic syndrome or acute myeloid leukemia
  • Known to be serologically positive for HIV and receiving antiretroviral therapy
  • Known seropositive for active viral infection with hepatitis B virus (HBV) (patients who are HBsAg negative, anti-HBs positive and/or hepatitis B core antigen (Anti-HBc) positive, but viral DNA negative are eligible)
  • Known seropositive for active infection with hepatitis C virus (HCV)
  • Patients unwilling or unable to comply with the protocol
  • Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure New York Heart Association (NYHA) III-IV or serious uncontrolled cardiac arrhythmias
  • Patients with an active or uncontrolled infection
  • Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer
  • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
  • Patients who have participated in another interventional clinical trial within 30 days before study entry
  • Other serious medical conditions that could impair the ability of the patient to participate in the study
  • Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
  • Active cancer (other than GCT) including prior malignancy from which the patient has been disease-free for ≤3 years (except superficial basal cell skin cancer)
  • Patients with a known hypersensitivity to the combination/comparator agent
  • Patients with uncontrolled seizures.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • U.O Oncologia Medica, IRST IRCCS

    Meldola, FC, 47014

  • Istituto Nazionale Tumori IRCCS "Fondazione G.Pascale"

    Naples, 80131

Other trials in Italy

About this study

This is open-label, single-arm, two-stage phase II trial of olaparib in patients with relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the safety of Olaparib in patients with cisplatin-refractory GCT.

Read the detailed description

This is a proof-of principle open-label, single-arm, two-stage phase II trial of olaparib 300 mg twice daily in patients with relapsed/refractory metastatic germ cell cancer. The study will recruit 10 patients, if no response is seen the study is terminated. If one or more responses are observed, further 19 patients (for a total of 29 patients) will be enrolled. If 4 or more of the first 29 evaluable patients have achieved objective response, further studies in patients with metastatic germ cell cancer are warranted.

The main inclusion criteria are:

  • Patient with metastatic gonadal GCT or extragonadal GCT originating from retroperitoneum or mediastinum.
  • Disease progression during cisplatin-based chemotherapy or disease progression or relapse after high-dose chemotherapy or disease progression or relapse after at least 2 different cisplatin-based regimens
  • At least one measurable lesion that can be accurately assessed by CT/MRI/plain x-ray) at baseline and follow up visits.

The study will be analyzed on an intent-to-treat basis. Secondary parameters will be analyzed exploratively for the intent-to-treat population.

Correlations between with biomarkers (PAR, poly adenosine diphosphate-ribose polymerase (PARP-1), PTEN, XPA, ERCC1-3, XPF, FanD2, γ-H2AX) expression in paraffin-embedded tumor samples and clinical outcome will be performed in an exploratory intent. Plasma samples will be collected at baseline and at response/progression for possible retrospective biomarkers study.

Being tested
Olaparib
Keywords
Cisplatin-resistant, Neoplasms, Germ Cell and Embryonal, Salvage treatment, olaparib
Medical subject headings
Neoplasms, Germ Cell and Embryonal

What participants receive

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

  • OlaparibDrug

    Also called AZD2281

    Olaparib dispensed to patients at the dose of 300 mg twice daily (BID) continuously until the patient completes the study, withdraws from the study or closure of the study.

Study groups in NCT02533765
Study groupRoleWhat they receive
OlaparibExperimentalOlaparib 300mg twice daily continuously
Receives: Drug: Olaparib

What is being measured

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

  1. Overall Response Rate (ORR)

    The percentage of patients whose cancer achieve either a partial response or a complete response.Tumor response will be assessed using CT scan or MRI of chest/abdomen using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and by tumor marker (AFP, betaHCG, LDH) measurements

    Measured: Up to 30 months

Secondary outcomes (4)

  1. Evaluation of number, type and grade of Adverse Events

    All patients will be evaluable for toxicity from the time of their first treatment with Olaparib

    Measured: Up to 30 months

  2. Progression free survival (PFS)

    time from the date of starting of the treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

    Measured: Up to 30 months

  3. Overall survival (OS)

    Time from enrolment to the date of death due to any cause. For subjects with no known date of death, survival time will be censored at the date of their last on-study assessment.

    Measured: Up to 30 months

  4. exploratory analysis of the association between PFS or OS and biomarkers

    correlation between biomarkers (PAR, PARP-1, PTEN, XPA, ERCC1-3, XPF, FanD2, γ-H2AX) in paraffin-embedded tumor samples and plasma with clinical outcome (response, PFS, OS)

    Measured: Up to 30 months

Timeline

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

  1. First posted27 Aug 2015 (estimated)
  2. Study start11 Sep 2015
  3. Primary completionSep 2018
  4. Study completion13 Feb 2023

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
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02533765
Sponsor's protocol ID
IRST186.02
Status last verified
Jan 2025
First submitted
17 Jun 2015
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib in people with Neoplasms, Germ Cell and Embryonal, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.

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 16 inclusion and 23 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: finished, as of the sponsor's last update on 30 Jan 2025. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Response Rate (ORR) (time frame: Up to 30 months). 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 NCT02533765.

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 30 Jan 2025.

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