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Advanced Ovarian CancerPhase 2ROLANDONCT03161132

Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin

A Phase 2 study testing Olaparib and Pegylated Liposomal Doxorubicin in people with Advanced Ovarian Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 8 sites in Spain.

Completed

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

Official record
Search all trials

Trial summary

Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Ovarian Cancer
What is being tested?
Olaparib and Pegylated Liposomal Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
8 sitesSpain
Study dates
13 Dec 2017to 31 Dec 2022
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and those obtained prior to signing of informed consent may be utilized for screening or for baseline purposes provided these procedures are conducted as specified in the protocol.
  • Patients with histological or cytological confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer and resistant platinum relapse with no prior treatment with PLD for their resistant relapse. Previous treatment with PLD is allowed as long as it was part of one platinum based regimen and the treatment was finalized at least six months previously to inclusion in this trial.
  • Patients must have platinum-resistant disease, defined as progression within <6 months from completion of at least 4 cycles of platinum and up to 3 prior chemotherapy regimens. Patients should have documented treatment-free interval of ≥6 months following 1st chemotherapy regimen received. Patients with a deleterious mutation in BRCA are eligible in any case with a resistant relapse including primary resistant relapse.
  • Have measurable disease as defined by RECIST v1.1 Criteria. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Female patients with > 18 years of age.
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  • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Haemoglobin ≥ 10.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; No features suggestive of Myelodysplastic Syndrome/Acute Myeloid Leukemia on peripheral blood smear; White blood cells (WBC) > 3x109/L; Platelet count ≥ 100 x 109/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); aspartate aminotransferase (AST/SGOT)/Alaninotransferase (ALT/SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN.
  • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min. PLD is metabolised by the liver and excreted in the bile. Population pharmacokinetic data (in the range of creatinine clearance tested of 30-156 ml/min) demonstrate that PLD clearance is not influenced by renal function. No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.
  • Patients must have a life expectancy ≥ 16 weeks.
  • Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1 Postmenopausal is defined as: Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments; luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50; Radiation-induced oophorectomy with last menses >1 year ago; Chemotherapy-induced menopause with >1 year interval since last menses; or surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • 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.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

Who cannot join

  • Platinum-refractory disease (progression during previous platinum therapy).
  • Involvement in the planning and/or conduct of the study (applies to both Sponsor staff and/or staff at the study site).
  • Previous enrolment in the present study.
  • Participation in another clinical study with an investigational product during the last 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment.
  • Any previous treatment with a PARP inhibitor, including olaparib.
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.
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  • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
  • Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
  • Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy.
  • Resting ECG with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • Blood transfusions within 28 days prior to study entry.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia.
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment.
  • Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high-resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Breast feeding women.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
  • Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
  • Patients with a known hypersensitivity to the combination/comparator agent
  • Patients with uncontrolled seizures.
  • Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Gran Canaria

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Son Llatzer

    Palma de Mallorca, Mallorca

  • Corporación Sanitaria Parc Taulí

    Sabadell, Barcelona

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

About this study

Official title: Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.

Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.

Read the detailed description

The combination of Poly (ADP-ribose) polymerase (PARP) inhibitors with PLD may provide a synergistic effect in patients with advanced ovarian cancer, especially those with Homologous recombination deficiency (HRD), because of the decreased ability to repair chemotherapy-induced DNA damage. Preclinical studies with PARP inhibitors have shown potentiation of the cytotoxic effects of chemotherapeutic agents and a recent phase I study has shown the tolerability of the combination and efficacy in recurrent ovarian cancer. In this study, encouraging efficacy results were seen in ovarian cancer patients and were not limited by Germline BRCA1/2 (gBRCA) Mutations status or sensitivity to platinum therapy.

Being tested
Olaparib, Pegylated Liposomal Doxorubicin

What participants receive

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

  • OlaparibDrug

    Also called Lynparza

    Combination of continous olaparib 300mg for oral administration plus Pegylated Liposomal Doxorubicin (PLD), followed by maintenance treatment further described.

  • Pegylated Liposomal DoxorubicinDrug

    Also called PLD

    PLD 40mg/m2 every 28 days intravenous

Study groups in NCT03161132
Study groupRoleWhat they receive
Olaparib 300mgExperimentalOlaparib bid orally at 300 mg (tablet formulation) continuously, combined with chemotherapy with Pegylated Liposomal Doxorubicin (up to 6 cycles), then, as monotherapy at the same dose and frequency (300mg bid orally) until progression of disease or unaccepted toxicity.
Receives: Drug: Olaparib
Pegylated Liposomal Doxorubicin (PLD)OtherPLD 40mg/m2 every 28 days intravenous for up to 6 cycles. This treatment will be combined with Olaparib (as described earlier).
Receives: Drug: Pegylated Liposomal Doxorubicin

What is being measured

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

  1. Progression-free Survival

    Proportion of pacients with no progression of disease at 6 months after start of treatment with Olaparib plus PLD

    Measured: 6 months

Secondary outcomes (7)

  1. Objective Response Rate

    Proportion of patients with tumor size reduction. Response duration is measured from the time of initial response until documented tumor progression. The Objective Response Rate (ORR) is defined as the sum of partial responses plus complete responses according to RECIST 1.1.

    Measured: 20 months

  2. Disease Control Rate

    Proportion of patients who have achieved complete response, partial response and stable disease of 8 or more months according to RECIST 1.1

    Measured: 20 months

  3. Response to treatment Rate according CA-125 levels

    Proportion of patients who have achieved a response according to CA-125: and it has occurred if there is at least a 50% reduction in CA-125 levels from a pretreatment sample.

    Measured: 20 months

  4. Progression-free survival

    Time from the date of the first dose of study treatment to the date of objective disease progression or death (in the absence of progression) regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression.

    Measured: 20 months

  5. Overall survival

    Time from inclusion until death of any cause.

    Measured: 20 months

  6. Health related quality of life

    Change in patient's quality of life during the study, using the self-reported European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) and the EORTC ovarian cancer module (EORTC-OV-28). Both scores will be combined to report a final outcome.

    Measured: 20 months

  7. Activity of tumor based on the growth modulation index (GMI)

    The GMI is the ratio of time to progression with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials.

    Measured: 20 months

Timeline

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

  1. First posted19 May 2017
  2. Study start13 Dec 2017
  3. Primary completion7 Feb 2020
  4. Study completion31 Dec 2022

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
Non-randomised
Intervention model
Single group
Model description
Multicentric
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161132
Sponsor's protocol ID
GEICO-1601
Other IDs
2016-004850-14, 2016
Acronym
ROLANDO
Status last verified
Jan 2023
First submitted
17 May 2017
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez-Fidalgo JA, Iglesias M, Bohn U, Calvo E, Garcia Y, Guerra E, Manso L, Santaballa A, Gonzalez-Martin A. GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer. Future Sci OA. 2019 Jan 10;5(2):FSO370. doi: 10.4155/fsoa-2018-0107. eCollection 2019 Feb.

    PubMed 30820349

  • Perez-Fidalgo JA, Cortes A, Guerra E, Garcia Y, Iglesias M, Bohn Sarmiento U, Calvo Garcia E, Manso Sanchez L, Santaballa A, Oaknin A, Redondo A, Rubio MJ, Gonzalez-Martin A. Olaparib in combination with pegylated liposomal doxorubicin for platinum-resistant ovarian cancer regardless of BRCA status: a GEICO phase II trial (ROLANDO study). ESMO Open. 2021 Aug;6(4):100212. doi: 10.1016/j.esmoop.2021.100212. Epub 2021 Jul 27.

    PubMed 34329939

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib and Pegylated Liposomal Doxorubicin in people with Advanced Ovarian Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 8 sites in Spain.

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 13 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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. 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?

Progression-free Survival (time frame: 6 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 NCT03161132, 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 27 Jan 2023.

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