<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02193633</url>
  </required_header>
  <id_info>
    <org_study_id>CCR3667</org_study_id>
    <secondary_id>2012-003896-20</secondary_id>
    <nct_id>NCT02193633</nct_id>
  </id_info>
  <brief_title>A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel.</brief_title>
  <acronym>TAX-TORC</acronym>
  <official_title>TAX-TORC: A Phase I Multi-centre Trial of the Combination of AZD2014 (Dual mTORC1 and mTORC2 Inhibitor) and Weekly Paclitaxel in Patients With Solid Tumours.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Cancer Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel&#xD;
      anticancer agent, in combination with paclitaxel.&#xD;
&#xD;
      AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,&#xD;
      4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment&#xD;
      break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will&#xD;
      be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.&#xD;
      Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off&#xD;
      schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel&#xD;
      infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of&#xD;
      AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.&#xD;
&#xD;
      On completion of the dose escalation phase of the study patients with ovarian cancer and&#xD;
      squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A&#xD;
      minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to&#xD;
      the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will&#xD;
      be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the&#xD;
      combination of AZD2014 and paclitaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-centre, Phase I clinical trial of the combination of AZD2014 and weekly&#xD;
      paclitaxel.&#xD;
&#xD;
      Two intermittent BD dosing schedules of AZD2014 in combination with paclitaxel will be&#xD;
      evaluated. The 3 days on 4 days off schedule will examine 3 continuous days of AZD2014 per&#xD;
      week in combination with weekly paclitaxel. The 2 days on 5 days off schedule will examine 2&#xD;
      sequential days of AZD2014 dosing in combination with weekly paclitaxel. For both schedules,&#xD;
      a dose escalation 3+3 design will be used to establish the MTD and the recommended Phase II&#xD;
      dose. Approximately 15 patients with solid tumours will be entered into each schedule during&#xD;
      the dose escalation of this phase.&#xD;
&#xD;
      The expansion part of the trial will be used to further assess the tolerability of AZD2014 in&#xD;
      combination with weekly paclitaxel. For the 3 days on 4 days off schedule 10 patients with&#xD;
      ovarian cancer and 15 patients with squamous lung cancer will be enrolled and treated at the&#xD;
      MTD established from the dose escalation phase. Accrual to these expansion arms may commence&#xD;
      as soon as the MTD is determined and proceed in parallel with the dose escalation phase of&#xD;
      the 2 days on 5 days off schedule. Once the MTD has been determined for the 2 days on 5 days&#xD;
      off schedule 15 patients with squamous lung cancer may be enrolled.&#xD;
&#xD;
      Determination of the MTD and decision to enter the expansion phase for each schedule will be&#xD;
      made by the Safety Review Committee (SRC) taking into consideration the safety data and&#xD;
      available PK/PD data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2013</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Establish the maximum tolerated dose and recommended Phase II dose of two intermittent dosing schedules of AZD2014: 3 days on, 4 days off and 2 days on, 5 days off in combination with weekly paclitaxel in patients with solid tumours.</measure>
    <time_frame>First cycle of treamtent (7 weeks)</time_frame>
    <description>To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays.</measure>
    <time_frame>First cycle of treatment (7 weeks)</time_frame>
    <description>To explore the effect of paclitaxel on the pharmacokinetics of AZD2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays</measure>
    <time_frame>First cycle of treatment (7 weeks)</time_frame>
    <description>Investigate the pharmacodynamics behaviour of the combination of AZD2014 and paclitaxel.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To document any possible anti-tumour activity</measure>
    <time_frame>Duration of the study</time_frame>
    <description>To determine disease response by RECIST criteria version 1.1, GCIG CA125 criteria and change in tumour size.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>AZD2014 3 on/4 off &amp; weekly paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 days on, 4 days off AZD2014 BD administered orally Days 1-3 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD2014 2 on/5 off &amp; weekly paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD2014 BD administered orally Days 1-2 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD2014 3 on/4 off &amp; weekly paclitaxel</intervention_name>
    <description>AZD2014 3 days on, 4 days off + weekly paclitaxel</description>
    <arm_group_label>AZD2014 3 on/4 off &amp; weekly paclitaxel</arm_group_label>
    <other_name>AZD2014</other_name>
    <other_name>AZD2014 3 days on, 4 days off</other_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD2014 2 on/5 off &amp; weekly paclitaxel</intervention_name>
    <description>AZD2014 2 days on, 5 Days off + weekly paclitaxel</description>
    <arm_group_label>AZD2014 2 on/5 off &amp; weekly paclitaxel</arm_group_label>
    <other_name>AZD2014</other_name>
    <other_name>AZD2014 2 days of, 5 days off</other_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically proven solid tumour.refractory to conventional&#xD;
             treatment, or for which no conventional therapy exists or is declined by the patient,&#xD;
             or where treatment with paclitaxel is an appropriate treatment option. Patients&#xD;
             enrolled in the expansion phase must have recurrent ovarian, fallopian tube or primary&#xD;
             peritoneal cancer only.&#xD;
&#xD;
          2. Patients who have had conventional treatment and where paclitaxel is appropriate. In&#xD;
             instances where paclitaxel is appropriate but the patients has not already received it&#xD;
             the patient may be enrolled after discussion between the referring oncologist and&#xD;
             Principal Investigator.&#xD;
&#xD;
          3. Life expectancy of at least 12 weeks&#xD;
&#xD;
          4. ECOG performance status of 0-1&#xD;
&#xD;
          5. Females should be using adequate contraceptive measures, should not be breast feeding&#xD;
             and must have a negative pregnancy test prior to start of dosing if of child-bearing&#xD;
             potential or must have evidence of non-child-bearing potential&#xD;
&#xD;
          6. Male patients should be willing to use barrier contraception i.e., condoms&#xD;
&#xD;
          7. Measurable or evaluable disease. Patients enrolled in the expansion phase should have&#xD;
             measurable disease by RECIST v1.1 criteria&#xD;
&#xD;
          8. Haematological and biochemical indices within the ranges shown below. These&#xD;
             measurements must be performed within one week (Day -7 to Day 1) before the patient&#xD;
             goes in the trial.&#xD;
&#xD;
               -  Haemoglobin (Hb)≥ 9.0 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1.5 x 109/L&#xD;
&#xD;
               -  Platelet count ≥ 100 x 109/L&#xD;
&#xD;
               -  Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤ 2.5 x (ULN)&#xD;
                  if no demonstrable liver metastases or ≤ 5 times ULN in the presence of liver&#xD;
                  metastases&#xD;
&#xD;
               -  Alkaline phosphatase (ALP)&lt; 5 x ULN&#xD;
&#xD;
               -  Creatinine Clearance ≥ 50 mL/min (uncorrected value)OR Serum creatinine ≤ 1.5 x&#xD;
                  ULN&#xD;
&#xD;
               -  Fasting glucose ≤ 125 mg/dL (7 mmol/L)&#xD;
&#xD;
               -  Erythrocyte-HbA1c ≤ 59 mmol/mol&#xD;
&#xD;
          9. 18 years or over&#xD;
&#xD;
         10. Written (signed and dated) informed consent and be capable of co-operating with&#xD;
             treatment and follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or&#xD;
             immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal&#xD;
             products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment.&#xD;
&#xD;
             N.B. Exceptions to this are patients receiving weekly taxol as standard of care who&#xD;
             have not had a partial or complete response after 6 to 12 weekly doses. Those patients&#xD;
             should discontinue their weekly taxol treatment and may be enrolled to the dose&#xD;
             expansion phase without a wash out period.&#xD;
&#xD;
          2. CTCAE Grade 1 or higher toxicities from previous systemic anticancer therapy prior to&#xD;
             the first dose of study treatment (with the exception of alopecia)&#xD;
&#xD;
          3. Known leptomeningeal involvement, brain metastases or spinal cord compression&#xD;
&#xD;
          4. Known hypersensitivity (&gt;Grade 2) to taxanes, drugs containing Cremophor, AZD2014 or&#xD;
             structurally/chemically similar drugs&#xD;
&#xD;
          5. Unresolved bowel obstruction&#xD;
&#xD;
          6. Current refractory nausea and vomiting, chronic gastrointestinal disease, inability to&#xD;
             swallow formulated product or previous significant bowel resection that would preclude&#xD;
             adequate absorption of AZD2014&#xD;
&#xD;
          7. Patients with Diabetes Type I or uncontrolled Type II (HbA1c &gt;59 mmol/mol assessed&#xD;
             locally) as judged by the investigator&#xD;
&#xD;
          8. Major surgery within 4 weeks prior to entry to the study (excluding placement of&#xD;
             vascular access), or minor surgery within 2 weeks of entry into the study and from&#xD;
             which the patient has not yet recovered&#xD;
&#xD;
          9. Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH.&#xD;
&#xD;
         10. Potent and moderate inhibitors and inducers of CYP3A4/5 if taken within the stated&#xD;
             washout periods:&#xD;
&#xD;
               -  Inhibitors (competitive): ketoconazole, itraconazole, indinavir, saquinovir,&#xD;
                  nelfinavir, atazanavir, amprenavir, fosamprenavir, troleandomycin, telithromycin,&#xD;
                  fluconazole, nefazodone, cimetidine, aprepitant, miconazole, fluvoxamine (1 week&#xD;
                  minimum wash-out period), amiodarone (27 week minimum wash-out period)&#xD;
&#xD;
               -  Inhibitors (time dependent): erythromycin, clarithromycin, verapamil, ritonavir,&#xD;
                  diltiazem (2 week minimum wash-out period)&#xD;
&#xD;
               -  Inducers: phenytoin, rifampicin, St. John's Wort, carbamazepine, primidone,&#xD;
                  griseofulvin, barbiturates, troglitazone, pioglitazone, oxcarbazepine,&#xD;
                  nevirapine, efavirenz, rifabutin (3 week minimum wash-out period) and&#xD;
                  phenobarbitone (5 week minimum washout period)&#xD;
&#xD;
         11. Potent and moderate inhibitors and inducers of CYP2C8 if taken within the stated&#xD;
             washout periods:&#xD;
&#xD;
               -  Inhibitors: Gemfibrozil, trimethoprim, glitazones, montelukast, quercetin (1 week&#xD;
                  minimum wash-out period)&#xD;
&#xD;
               -  Inducers: Rifampicin (3 week minimum wash-out period)&#xD;
&#xD;
         12. At high medical risk because of non-malignant systemic disease including active&#xD;
             uncontrolled infection e.g. interstitial lung disease, severe hepatic impairment,&#xD;
             uncontrolled chronic renal disease&#xD;
&#xD;
         13. Known to be serologically positive for hepatitis B, hepatitis C or human&#xD;
             immunodeficiency virus (HIV).&#xD;
&#xD;
         14. Patients who have experienced any of the following procedures or conditions currently&#xD;
             or in the preceding 12 months:&#xD;
&#xD;
               -  coronary artery bypass graft&#xD;
&#xD;
               -  angioplasty&#xD;
&#xD;
               -  vascular stent&#xD;
&#xD;
               -  myocardial infarction (MI)&#xD;
&#xD;
               -  uncontrolled angina pectoris&#xD;
&#xD;
               -  congestive heart failure NYHA Grade 2&#xD;
&#xD;
               -  ventricular arrhythmias requiring continuous therapy&#xD;
&#xD;
               -  supraventricular arrhythmias including AF, which are uncontrolled&#xD;
&#xD;
               -  Torsades de Pointes&#xD;
&#xD;
               -  haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any&#xD;
                  other central nervous system bleeding&#xD;
&#xD;
         15. Resting ECG with measurable QTc interval of &gt;470ms msec at 2 or more time points&#xD;
             within a 24 hour period.&#xD;
&#xD;
         16. Concomitant medications known to prolong QT interval, or with factors that increase&#xD;
             the risk of QTc prolongation or risk of arrhythmic events (such as heart failure,&#xD;
             hypokalaemia, congenital long QT syndrome, family history of long QT syndrome), or&#xD;
             unexplained sudden death under 40 years of age. Inability to discontinue medication&#xD;
             with agents designated as having a risk of Torsades de Pointes due to QT prolongation&#xD;
             (see Appendix 5)&#xD;
&#xD;
         17. Left ventricular (LV) dysfunction (LVEF outside institutional range of normal) by MUGA&#xD;
             or Echocardiogram.&#xD;
&#xD;
         18. Current malignancies of other types, with the exception of adequately treated&#xD;
             cone-biopsied in situ carcinoma of the cervix, uteri and basal or squamous cell&#xD;
             carcinoma of the skin. Cancer survivors, who have undergone potentially curative&#xD;
             therapy for a prior malignancy, have no evidence of that disease for three years or&#xD;
             more and are deemed at negligible risk for recurrence, are eligible for the trial.&#xD;
&#xD;
         19. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of&#xD;
             bone marrow within eight weeks of starting trial&#xD;
&#xD;
         20. Patients participating in or planning to participate in another interventional&#xD;
             clinical trial whilst on this study. Participation in an observational trial is&#xD;
             acceptable.&#xD;
&#xD;
         21. Any other condition which in the Investigator's opinion would not make the patient a&#xD;
             good candidate for the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Udai Banerji, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Institute of Cancer Research, Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas's NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>June 10, 2013</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193633
org study id: CCR3667
secondary id: 2012-003896-20
nct id: NCT02193633
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel
      anticancer agent, in combination with paclitaxel.

      AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,
      4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment
      break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will
      be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.
      Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off
      schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel
      infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of
      AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.

      On completion of the dose escalation phase of the study patients with ovarian cancer and
      squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A
      minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to
      the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will
      be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the
      combination of AZD2014 and paclitaxel.
This is a multi-centre, Phase I clinical trial of the combination of AZD2014 and weekly
      paclitaxel.

      Two intermittent BD dosing schedules of AZD2014 in combination with paclitaxel will be
      evaluated. The 3 days on 4 days off schedule will examine 3 continuous days of AZD2014 per
      week in combination with weekly paclitaxel. The 2 days on 5 days off schedule will examine 2
      sequential days of AZD2014 dosing in combination with weekly paclitaxel. For both schedules,
      a dose escalation 3+3 design will be used to establish the MTD and the recommended Phase II
      dose. Approximately 15 patients with solid tumours will be entered into each schedule during
      the dose escalation of this phase.

      The expansion part of the trial will be used to further assess the tolerability of AZD2014 in
      combination with weekly paclitaxel. For the 3 days on 4 days off schedule 10 patients with
      ovarian cancer and 15 patients with squamous lung cancer will be enrolled and treated at the
      MTD established from the dose escalation phase. Accrual to these expansion arms may commence
      as soon as the MTD is determined and proceed in parallel with the dose escalation phase of
      the 2 days on 5 days off schedule. Once the MTD has been determined for the 2 days on 5 days
      off schedule 15 patients with squamous lung cancer may be enrolled.

      Determination of the MTD and decision to enter the expansion phase for each schedule will be
      made by the Safety Review Committee (SRC) taking into consideration the safety data and
      available PK/PD data.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Establish the maximum tolerated dose and recommended Phase II dose of two intermittent dosing schedules of AZD2014: 3 days on, 4 days off and 2 days on, 5 days off in combination with weekly paclitaxel in patients with solid tumours.
time frame: First cycle of treamtent (7 weeks)
description: To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity.
measure: PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays.
time frame: First cycle of treatment (7 weeks)
description: To explore the effect of paclitaxel on the pharmacokinetics of AZD2014
measure: PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays
time frame: First cycle of treatment (7 weeks)
description: Investigate the pharmacodynamics behaviour of the combination of AZD2014 and paclitaxel.
measure: To document any possible anti-tumour activity
time frame: Duration of the study
description: To determine disease response by RECIST criteria version 1.1, GCIG CA125 criteria and change in tumour size.
arm group label: AZD2014 3 on/4 off & weekly paclitaxel
arm group type: Experimental
description: 3 days on, 4 days off AZD2014 BD administered orally Days 1-3 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).
arm group label: AZD2014 2 on/5 off & weekly paclitaxel
arm group type: Experimental
description: AZD2014 BD administered orally Days 1-2 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).
intervention type: Drug
intervention name: AZD2014 3 on/4 off & weekly paclitaxel
description: AZD2014 3 days on, 4 days off + weekly paclitaxel
arm group label: AZD2014 3 on/4 off & weekly paclitaxel
other name: AZD2014
other name: AZD2014 3 days on, 4 days off
other name: Paclitaxel
intervention type: Drug
intervention name: AZD2014 2 on/5 off & weekly paclitaxel
description: AZD2014 2 days on, 5 Days off + weekly paclitaxel
arm group label: AZD2014 2 on/5 off & weekly paclitaxel
other name: AZD2014
other name: AZD2014 2 days of, 5 days off
other name: Paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Udai Banerji, PhD
role: Principal Investigator
affiliation: The Institute of Cancer Research, Royal Marsden NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel