Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors

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Brief Title

Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors

Official Title

Phase Ib/II Study to Evaluate the Efficacy and Tolerability of PM01183 in Combination With Olaparib in Patients With Advanced Solid Tumors

Brief Summary

      Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with
      olaparib in patients with advanced solid tumors.
    

Detailed Description

      The study will be split into 2 parts: an open label Phase I dose escalation part followed by
      a non-randomized Phase II part, as an expansion study, in patients with selected tumors at
      the recommended doses and schedule determined in the phase I.

      Phase I: A dose escalation study will be performed in patients with advanced or metastatic
      solid tumors without established standard therapeutic alternatives.

      Phase II: An expansion dose study selecting patients with potential tumors with possibly
      sensitivity to PARP inhibitors according to histology, including triple negative breast
      cancer, high grade serous platinum-resistant ovarian and endometrial cancer patients, or
      patients with molecular features such as endometrial cancer with PTEN loss, breast or ovarian
      cancer with PTEN loss, known BRCA1/2 germline, somatic mutation or somatic methylation.

      OBJECTIVES:

      Primary objectives:

      Phase Ib: To establish the safety [dose limiting toxicity (DLT), maximum tolerated dose (MTD)
      and recommended Phase II doses (RP2D)], of orally administered olaparib in combination with
      PM01183 in patients with advanced or metastatic solid tumors without established standard
      therapeutic alternatives.

      Phase II: To assess the efficacy in terms of Tumor response rate according to RECIST v1.1
      criteria of PM01183 in combination with olaparib in the selected populations.

      Secondary objectives

      Phase Ib:

      To explore the pharmacokinetics of PM01183 and olaparib when administered in combination. To
      determine the effects of the study treatment on the level of PARP activity and

      DNA damage in:

        -  Peripheral blood mononuclear cells (PBMC).

        -  Circulating tumor cells (CTC).

        -  Tumor biopsy samples. To evaluate the preliminary antitumor activity (overall response
           rate) by RECIST of the combination in the exposed population.

      Phase II:

      Progression free survival. Overall Survival. Toxicity profile of the combination in patients
      enrolled in the study. To explore the possible correlation between the expression of certain
      biomarkers and the efficacy of this therapeutic approach.

      STATISTICAL PROCEDURES

      - Sample size. Justification

      Phase I:

      Between 18-48 patients are expected to participate in the Phase Ib part of the study. The
      number of patients may vary depending upon the tolerability of the combination and the number
      of dose levels required to identify the MTD.

      Phase II:

      A total accrual up to 73 subjects would be required, according to an MinMax two-stages Simon
      design. With an α-error 0.05 and a power 90%, RR with a poor scenario according previous one
      would be 24%, and in a favourable scenario RR would reach 40%.

      Progression-free survival according to previous reported is 3.5 months and the objective for
      the study is 6.5 months (n=56). According to this objective, the maximum sample size is 73
      patients, and first sample size is 61 patients (upper limit for first stage rejection: 18).

      Two stages are established:

        1. In the first step 61 evaluable patients will be included in the study. If 18 or fewer
           responses are observed, the study will be stopped due to an inadequate response rate.

           Efficacy data for the patients included at this first step will be reviewed by an
           independent assessment committee (IAC).

        2. If 19 or more responses are observed recruitment will continue until the group has 73
           evaluable patients. If 23 or fewer responses are detected among these 73 patients, it
           will be concluded that the regimen is not sufficiently active to warrant further
           testing. If 24 or more responses are observed it will be concluded that the regimen is
           sufficiently active to warrant further testing in posterior Phase III.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Dose limiting toxicity

Secondary Outcome

 Pharmacodynamic evaluation to assess the increasing activity in DNA damage

Condition

Advanced Cancer

Intervention

PM01183 + olaparib

Study Arms / Comparison Groups

 Dose Level 1
Description:  PM01183 + olaparib PM01183: 1 mg/m² IV olaparib 100 mg BID

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

July 2015

Completion Date

October 2019

Primary Completion Date

July 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥18 years of age, no upper age limit.

          -  Written informed consent obtained prior to any study specific procedures or
             assessments.

          -  Histologically confirmed diagnosis of cancer:

               1. Phase I: patients with advanced or metastatic solid tumors without established
                  standard therapeutic alternatives.

               2. Phase II: platinum-resistant ovarian cancer patients (epithelial non-mucinous),
                  triple negative breast cancer and endometrial cancer (any grade).

          -  For patients included in the phase II part of the study, evidence of measurable
             disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
             is required.

               1. 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, OR

               2. At least one lesion (measurable and/or non-measurable) that can be accurately
                  assessed by (CT/MRI/plain x-ray) at baseline and follow up visits.

          -  Patients included in the phase II part of the study must have received at least one
             line of standard therapy for locally advanced or metastatic disease, and developed
             progression disease afterwards.

          -  ECOG score < 2.

          -  Life expectancy of ≥ 3 months.

          -  Patients must have normal organ and bone marrow function measured within 28 days prior
             to administration of study treatment as defined below:

               1. Haemoglobin ≥ 10.0 g/dL and no blood transfusions in the 28 days prior to
                  entry/randomisation (choose whichever is most applicable to the study).

               2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

             i. No features suggestive of myelodisplastic syndrome (MSD)/ Acute myeloid leukaemia
             (AML) on peripheral blood smear c. White blood cells (WBC) > 3x109/L d. Platelet count
             ≥ 100 x 109/L e. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) f.
             AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present in
             which case it must be ≤ 5x ULN g. Albumin ≥ 3.0 g/dl h. Serum creatinine ≤ 1.5 x
             institutional ULN i. Creatinine clearance ≥ 30 ml/min.

          -  Patients should sign an informed consent form before inclusion in the study that
             specifies that the clinical trial treatment entails consent for the analysis of
             biological samples of tumor and blood.

          -  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.

          -  Evidence of non-childbearing status for women of childbearing potential (WOCBP)*.

        WOCBP should only be included after a confirmed menstrual period and a negative urine or
        serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day
        1.. The inclusion of WOCBP requires use of a highly effective contraceptive measure
        (Appendix H).

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          -  Involvement in the planning and/or conduct of the study.

          -  Previous enrolment or randomization in the present study.

          -  Simultaneous participation in any other study involving an investigational medicinal
             product, or having participated in a study less than 28 days prior to the start of
             study treatment.

          -  For patients included in the phase I of the study, previous treatment with olaparib or
             PM01183. For patients included in the phase II of the study, any previous treatment
             with a PARP inhibitor, including olaparib, or PM01183.

          -  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.

          -  Olaparib and PM01183 are metabolized mainly by CYP3A4. Therefore, concomitant use of
             known strong CYP3A4 inhibitors such as ketokonazole, itraconazole, telithromycin and
             clarithromycin are forbidden. Concomitant use of known CYP3A4 strong inducers. (See
             Appendix K for a list of CYP inducers, inhibitors and substrates).

          -  Persistent toxicities (≥ CTCAE grade 2) with the exception of alopecia, caused by
             previous cancer therapy.

          -  Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or
             family history of long QT syndrome.

          -  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 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 who present any contraindication or suspected allergy to the products (or any
             of the excipients) under investigation in the study.

          -  Patients with uncontrolled seizures.

          -  For patients included at the phase II part of the study: patients with second primary
             cancer, except: adequately treated non-melanoma skin cancer, curatively treated insitu
             cancer of the cervix, or other solid tumours curatively treated with no evidence of
             disease for ≥ 5 years.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andres Poveda, MD, 0034961104647, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT02684318

Organization ID

POLA/ACOG1401


Responsible Party

Sponsor

Study Sponsor

Poveda, Andrés, M.D.

Collaborators

 AstraZeneca

Study Sponsor

Andres Poveda, MD, Principal Investigator, Fundación Instituto Valenciano de Oncología


Verification Date

June 2017