Advanced Solid TumorsPhase 1NCT01009190
A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
A Phase 1 study testing PF-01367338 and Carboplatin in people with Advanced Solid Tumors, run by pharmaand GmbH at 6 sites in United Kingdom.
Trial summary
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PF-01367338 and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Feb 2010to Apr 2014
- Phase
- Phase 1
- 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 with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Patients with acceptable renal, hepatic, and bone marrow function
Who cannot join
- Symptomatic and/or unstable brain metastases,
- Any cancer treatment within 4 weeks from study entry
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Belfast City Hospital
Belfast, BT9 7AB
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Kings College London
London, SE1 9RT
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, NE7 7DN
Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- PF-01367338, Carboplatin
- Keywords
- Dose finding PARPi Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-01367338Drug
Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle
CarboplatinDrug
Standard doses of intravenous Carboplatin administered every 3 weeks
PF-01367338Drug
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
CarboplatinDrug
Standard doses of intravenous Carboplatin administered every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Carboplatin plus PF-01367338 Receives: Drug: PF-01367338; Drug: Carboplatin |
| ARM A EXPANSION | Experimental | Carboplatin plus PF-01367338 Receives: Drug: PF-01367338; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
Dose-limiting toxicities and adverse events
Measured: 18 months
Secondary outcomes (9)
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time to attain maximum plasma concentration [Tmax]
Measured: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
maximum plasma concentration (CMax)
Measured: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
area under plasma concentration curve (AUC)
Measured: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
apparent terminal half-life (t1/2)
Measured: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
rucaparib oral bioavailability
Measured: 18 months
PARP activity and expression in peripheral blood lymphocytes (PBL)
% PARP activity
Measured: 18 months
Determination of food effect on oral PF-01367338 pharmacokinetics
fasted and fed parameters area under the plasma concentration-time curve from time 0 to the last recorded observation [AUClast]
Measured: 18 month
Determination of food effect on oral PF-01367338 pharmacokinetics
fasted and fed maximum plasma concentration (Cmax)
Measured: 18 month
Determination of effect of PF-013567338 administration on QTc prolongation test
electrocardiogram[ecg], QTcF, QTcB
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startFeb 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- pharmaand GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009190
- Sponsor's protocol ID
- CO-338-1014
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2009
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
PubMed 35397664Wilson RH, Evans TJ, Middleton MR, Molife LR, Spicer J, Dieras V, Roxburgh P, Giordano H, Jaw-Tsai S, Goble S, Plummer R. A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer. 2017 Mar 28;116(7):884-892. doi: 10.1038/bjc.2017.36. Epub 2017 Feb 21.
PubMed 28222073
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT01009190
- Acronym / sponsor ID
- CO-338-1014
- Conditions
- Advanced Solid Tumors
- Keywords
- Dose finding PARPi Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- pharmaand GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: PF-01367338, Drug: CarboplatinCarboplatin plus PF-01367338 |
| ARM A EXPANSION | Experimental | Drug: PF-01367338, Drug: CarboplatinCarboplatin plus PF-01367338 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Patients with acceptable renal, hepatic, and bone marrow function
Key exclusion criteria (2 listed)
- Symptomatic and/or unstable brain metastases,
- Any cancer treatment within 4 weeks from study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-01367338Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle | Drug | ARM A |
| CarboplatinStandard doses of intravenous Carboplatin administered every 3 weeks | Drug | ARM A |
| PF-01367338RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle | Drug | ARM A EXPANSION |
| CarboplatinStandard doses of intravenous Carboplatin administered every 3 weeks | Drug | ARM A EXPANSION |
Primary outcome
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
Time frame: 18 months
Dose-limiting toxicities and adverse events
9 secondary outcomes
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time frame: 18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time frame: 18 months
PARP activity and expression in peripheral blood lymphocytes (PBL)
Time frame: 18 months
Determination of food effect on oral PF-01367338 pharmacokinetics
Time frame: 18 month
Determination of food effect on oral PF-01367338 pharmacokinetics
Time frame: 18 month
Determination of effect of PF-013567338 administration on QTc prolongation test
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 35397664Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
- Derived from this study: PubMed 28222073Wilson RH, Evans TJ, Middleton MR, Molife LR, Spicer J, Dieras V, Roxburgh P, Giordano H, Jaw-Tsai S, Goble S, Plummer R. A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer. 2017 Mar 28;116(7):884-892. doi: 10.1038/bjc.2017.36. Epub 2017 Feb 21.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-01367338 and Carboplatin in people with Advanced Solid Tumors, run by pharmaand GmbH at 6 sites in United Kingdom.
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 2 inclusion and 2 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 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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 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.
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?
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) (time frame: 18 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 NCT01009190, 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 8 Jun 2023.